Trial Outcomes & Findings for A Study of Belimumab in the Prevention of Kidney Transplant Rejection (NCT NCT01536379)

Last Updated: 2017-04-25

Results Overview

Naive B cell is cell that is not exposed to antigen. Naïve B cell count is CD20+CD27 concentration of cells (conc-cell)/cubic millimeter (cumm). Change from Baseline in naïve B cells was calculated as the value at Week 24 minus the value at Baseline. MITT Population consisted of all participants randomized to treatment, who have had taken at least one dose of study. Participants analyzed included those who had data at Week 24 for naïve B cells count (MITT Population). Baseline value used in the analysis was of Day 0 (Day of transplant). Adjusted mean differences (treatment-placebo) and 95% confidence intervals for differences were obtained from mixed-models repeated-measures (MMRM) model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2017-04-25

Participant Flow

A total of 30 renal transplant recipients were enrolled, of which 28 were randomized and 25 were transplanted.

Participants were randomized to 1 of the 2 treatments groups in a 1:1 ratio and received standard of care in addition to investigational products (IPs). Participants received IP infusion on Day 0, Day 14, Day 28 and every 4 weeks thereafter for a total of 7 infusions.

Participant milestones

Participant milestones
Measure	Placebo Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Overall Study STARTED	13	12
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Overall Study Adverse Event	1	2
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

A Study of Belimumab in the Prevention of Kidney Transplant Rejection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Total n=25 Participants Total of all reporting groups
Age, Continuous	51.0 Years STANDARD_DEVIATION 14.02 • n=5 Participants	54.3 Years STANDARD_DEVIATION 11.02 • n=7 Participants	52.6 Years STANDARD_DEVIATION 12.52 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Modified Intent to treat (MITT) Population

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=7 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Change From Baseline in naïve B Cells From Baseline to Week 24	4.0 cells/mm^3 Standard Error 25.55	-30.4 cells/mm^3 Standard Error 27.50

PRIMARY outcome

Timeframe: Up to 1 year

Population: mITT Population

Number of participants with AEs, SAEs and AESI are summarized. The On-treatment (OT) phase started on the day and time of receiving the start of the first infusion and ended on the last dose date plus 28 days. The Post-treatment (PT) phase started 29 days after day of last dose up to 1 year. An AE is any untoward medical occurrence, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in, death, is life threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect or event that but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed. AESI included malignant neoplasms, infusion/anaphylaxis/hypersensitivity reactions, all infections, depression/suicide/self-injury, deaths.

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) Post-Infusion Systemic Reactions	0 Participants	1 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) All Infections	6 Participants	7 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) Depression/suicide/self-injury	0 Participants	0 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) Deaths	1 Participants	0 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) OT AEs	10 Participants	11 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) PT AEs	9 Participants	10 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) OT SAEs	7 Participants	5 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) PT SAEs	2 Participants	2 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) Malignant neoplasms	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: mITT Population

All infections included: 1. Opportunistic infections per-clinical assessment, 2. Herpes Zoster, a. Recurrent, b. Disseminated, 3. Sepsis. Opportunistic infections were identified using list of preferred terms as per Medical Dictionary for Regulatory Activities (MedDRA) version 18.1. Any events falling under these preferred terms were adjudicated to determine if criteria was met for an opportunistic infection.

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Number of Incidence of All Infections and Serious Infections All Infections	8 Infections	7 Infections
Number of Incidence of All Infections and Serious Infections Serious Infections	2 Infections	1 Infections
Number of Incidence of All Infections and Serious Infections All Opportunistic Infections	7 Infections	5 Infections
Number of Incidence of All Infections and Serious Infections Serious Opportunistic Infections	1 Infections	0 Infections
Number of Incidence of All Infections and Serious Infections All Herpes Zoster	0 Infections	1 Infections
Number of Incidence of All Infections and Serious Infections Serious Herpes Zoster	0 Infections	0 Infections
Number of Incidence of All Infections and Serious Infections Sepsis	3 Infections	2 Infections
Number of Incidence of All Infections and Serious Infections Serious Sepsis	2 Infections	1 Infections

PRIMARY outcome

Timeframe: Baseline, Week 24 and Week 52

Population: mITT Population

Change from Baseline in SBP and DBP were assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24 and Week 52 DBP Week 24; n=9, 7	-4.444 millimeter of mercury (mmHg) Standard Deviation 14.3275	7.286 millimeter of mercury (mmHg) Standard Deviation 13.8289
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24 and Week 52 DBP Week 52; n=11, 10	-6.545 millimeter of mercury (mmHg) Standard Deviation 13.9668	4.200 millimeter of mercury (mmHg) Standard Deviation 8.5479
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24 and Week 52 SBP Week 24; n=9, 7	2.000 millimeter of mercury (mmHg) Standard Deviation 26.0960	10.000 millimeter of mercury (mmHg) Standard Deviation 35.9444
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24 and Week 52 SBP Week 52; n=11, 10	-2.909 millimeter of mercury (mmHg) Standard Deviation 27.2046	3.300 millimeter of mercury (mmHg) Standard Deviation 27.9008

PRIMARY outcome

Timeframe: Baseline, Week 24 and Week 52

Population: mITT Population

Change from Baseline in heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Change From Baseline in Heart Rate From Baseline at Week 24 and Week 52 Week 24; n=8, 6	5.125 Beats per minute (BPM) Standard Deviation 16.8983	1.500 Beats per minute (BPM) Standard Deviation 13.6345
Change From Baseline in Heart Rate From Baseline at Week 24 and Week 52 Week 52; n=11, 9	2.000 Beats per minute (BPM) Standard Deviation 11.5065	-2.444 Beats per minute (BPM) Standard Deviation 15.4200

PRIMARY outcome

Timeframe: Baseline, Week 24 and Week 52

Population: mITT Population

Change from Baseline in body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Change From Baseline in Body Temperature From Baseline at Week 24 and Week 52 Week 24; n=8, 6	0.025 Degree Centigrade Standard Deviation 0.7025	-0.233 Degree Centigrade Standard Deviation 0.5007
Change From Baseline in Body Temperature From Baseline at Week 24 and Week 52 Week 52; n=11, 10	-0.045 Degree Centigrade Standard Deviation 0.4803	0.030 Degree Centigrade Standard Deviation 0.5417

PRIMARY outcome

Timeframe: Week 24 and Week 52

Population: mITT Population

Number of participants outside the normal range (NR) for SBP and DBP was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (\<) normal range and greater than (\>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52 DBP, > NR, Week 24; n=9, 7	1 Participants	1 Participants
Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52 DBP, < NR, Week 24; n=9, 7	1 Participants	2 Participants
Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52 DBP, > NR, Week 52; n=11, 10	3 Participants	0 Participants
Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52 DBP, < NR, Week 52; n=11, 10	2 Participants	1 Participants
Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52 SBP, > NR, Week 24; n=9, 7	5 Participants	3 Participants
Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52 SBP, < NR, Week 24; n=9, 7	0 Participants	0 Participants
Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52 SBP, > NR, Week 52; n=11, 10	5 Participants	4 Participants
Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52 SBP, < NR, Week 52; n=11, 10	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Week 24 and Week 52

Population: mITT Population

Number of participants outside the normal range (NR) for heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (\<) normal range and greater than (\>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Number of Participants Outside the Normal Range (NR) for Heart Rate at Week 24 and Week 52 > NR Week 24; n=8, 6	1 Participants	0 Participants
Number of Participants Outside the Normal Range (NR) for Heart Rate at Week 24 and Week 52 < NR Week 24; n=8, 6	2 Participants	0 Participants
Number of Participants Outside the Normal Range (NR) for Heart Rate at Week 24 and Week 52 > NR Week 52; n=11, 9	0 Participants	0 Participants
Number of Participants Outside the Normal Range (NR) for Heart Rate at Week 24 and Week 52 < NR Week 52; n=11, 9	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Week 24 and Week 52

Population: mITT Population

Number of participants outside the normal range (NR) for body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (\<) normal range and greater than (\>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Number of Participants Outside the Normal Range (NR) for Body Temperature at Week 24 and Week 52 > NR Week 24; n=8, 6	0 Participants	0 Participants
Number of Participants Outside the Normal Range (NR) for Body Temperature at Week 24 and Week 52 < NR Week 24; n=8, 6	3 Participants	4 Participants
Number of Participants Outside the Normal Range (NR) for Body Temperature at Week 24 and Week 52 > NR Week 52; n=11, 10	0 Participants	0 Participants
Number of Participants Outside the Normal Range (NR) for Body Temperature at Week 24 and Week 52 < NR Week 52; n=11, 10	5 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24 and Week 52

Population: mITT Population

Hematology parameters included: basophils (B), eosinophils (E), lymphocytes (L), monocytes (M), total neutrophils (N), platelet count (PC) and white blood cells (WBC). Change from Baseline in haematology parameter was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52 TN Week 24; n=9, 6	0.946 Gills/Liter (GI/L) Standard Deviation 2.6602	-0.083 Gills/Liter (GI/L) Standard Deviation 2.4752
Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52 E Week 24; n=9, 6	-0.531 Gills/Liter (GI/L) Standard Deviation 1.0250	-0.140 Gills/Liter (GI/L) Standard Deviation 0.1274
Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52 E Week 52; n=10, 10	-0.392 Gills/Liter (GI/L) Standard Deviation 0.8048	-0.127 Gills/Liter (GI/L) Standard Deviation 0.1489
Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52 B Week 24; n=9, 6	-0.001 Gills/Liter (GI/L) Standard Deviation 0.0215	-0.015 Gills/Liter (GI/L) Standard Deviation 0.0207
Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52 B Week 52; n=10, 10	0.033 Gills/Liter (GI/L) Standard Deviation 0.1024	-0.005 Gills/Liter (GI/L) Standard Deviation 0.0357
Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52 L Week 24; n=9, 6	-0.218 Gills/Liter (GI/L) Standard Deviation 0.6457	-0.347 Gills/Liter (GI/L) Standard Deviation 0.3467
Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52 L Week 52; n=10, 10	0.085 Gills/Liter (GI/L) Standard Deviation 0.5841	-0.245 Gills/Liter (GI/L) Standard Deviation 0.3357
Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52 M Week 24; n=9, 6	-0.097 Gills/Liter (GI/L) Standard Deviation 0.2231	-0.365 Gills/Liter (GI/L) Standard Deviation 0.3509
Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52 M Week 52; n=10, 10	0.001 Gills/Liter (GI/L) Standard Deviation 0.1799	-0.111 Gills/Liter (GI/L) Standard Deviation 0.3892
Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52 TN Week 52; n=10, 10	1.657 Gills/Liter (GI/L) Standard Deviation 3.5533	-0.606 Gills/Liter (GI/L) Standard Deviation 3.3406
Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52 PC Week 24; n=9, 6	15.9 Gills/Liter (GI/L) Standard Deviation 59.64	7.3 Gills/Liter (GI/L) Standard Deviation 40.35
Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52 PC Week 52; n=11, 10	18.1 Gills/Liter (GI/L) Standard Deviation 55.81	-10.0 Gills/Liter (GI/L) Standard Deviation 54.14
Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52 WBC Week 24; n=9, 6	0.10 Gills/Liter (GI/L) Standard Deviation 3.483	-0.95 Gills/Liter (GI/L) Standard Deviation 2.868
Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52 WBC Week 52; n=11, 10	1.47 Gills/Liter (GI/L) Standard Deviation 3.572	-1.11 Gills/Liter (GI/L) Standard Deviation 3.557

PRIMARY outcome

Timeframe: Baseline, Week 24 and Week 52

Population: mITT Population

Change from Baseline in hemoglobin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Change From Baseline in the Haematology Parameter- Hemoglobin at Week 24 and Week 52 Week 24; n=9, 6	5.4 Grams per Liter (G/L) Standard Deviation 24.84	13.2 Grams per Liter (G/L) Standard Deviation 28.90
Change From Baseline in the Haematology Parameter- Hemoglobin at Week 24 and Week 52 Week 52; n=11, 10	12.6 Grams per Liter (G/L) Standard Deviation 22.69	6.3 Grams per Liter (G/L) Standard Deviation 23.48

PRIMARY outcome

Timeframe: Baseline, Week 24 and Week 52

Population: mITT Population

Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Change From Baseline in the Hematology Parameter- Hematocrit at Week 24 and Week 52 Week 24; n=9, 6	0.0216 Percentage of blood Standard Deviation 0.06625	0.0477 Percentage of blood Standard Deviation 0.09540
Change From Baseline in the Hematology Parameter- Hematocrit at Week 24 and Week 52 Week 52; n=11, 10	0.0434 Percentage of blood Standard Deviation 0.06813	0.0238 Percentage of blood Standard Deviation 0.07045

PRIMARY outcome

Timeframe: Baseline, Week 24 and Week 52

Population: mITT Population

Change from Baseline in MCH was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Change From Baseline in Haematology Parameter- Mean Corposcular Hemoglobin (MCH) at Week 24 and Week 52 Week 52; n=10, 10	-1.59 Picogram (pg) Standard Deviation 1.516	-1.93 Picogram (pg) Standard Deviation 2.743
Change From Baseline in Haematology Parameter- Mean Corposcular Hemoglobin (MCH) at Week 24 and Week 52 Week 24; n=8, 6	-0.79 Picogram (pg) Standard Deviation 2.173	-1.37 Picogram (pg) Standard Deviation 2.683

PRIMARY outcome

Timeframe: Baseline, Week 24 and Week 52

Population: mITT Population

Change from Baseline in MCV was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Change From Baseline in Haematology Parameter- Mean Corposcular Volume (MCV) at Week 24 and Week 52 Week 24; n=9, 6	-1.73 Femtoliter (FL) Standard Deviation 6.430	-2.55 Femtoliter (FL) Standard Deviation 8.198
Change From Baseline in Haematology Parameter- Mean Corposcular Volume (MCV) at Week 24 and Week 52 Week 52; n=11, 10	-3.58 Femtoliter (FL) Standard Deviation 4.340	-4.61 Femtoliter (FL) Standard Deviation 7.041

PRIMARY outcome

Timeframe: Baseline, Week 24 and Week 52

Population: mITT Population

Change from Baseline in RBC was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Change From Baseline in Haematology Parameter- Red Blood Cell (RBC) at Week 24 and Week 52 Week 24; n=9, 6	0.298 Tera (TI)/L Standard Deviation 0.6716	0.645 Tera (TI)/L Standard Deviation 0.8097
Change From Baseline in Haematology Parameter- Red Blood Cell (RBC) at Week 24 and Week 52 Week 52; n=11, 10	0.635 Tera (TI)/L Standard Deviation 0.7064	0.468 Tera (TI)/L Standard Deviation 0.5884

PRIMARY outcome

Timeframe: Baseline, Week 24 and Week 52

Population: mITT Population

Change from Baseline in albumin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Change From Baseline in Clinical Chemistry Parameter- Albumin at Week 24 and Week 52 Week 24; n=9, 7	4.1 G/L Standard Deviation 2.62	2.9 G/L Standard Deviation 4.91
Change From Baseline in Clinical Chemistry Parameter- Albumin at Week 24 and Week 52 Week 52; n=10, 10	2.9 G/L Standard Deviation 3.00	1.8 G/L Standard Deviation 4.98

PRIMARY outcome

Timeframe: Baseline, Week 24 and Week 52

Population: mITT Population

Clinical chemistry parameter included alkaline phosphatase (ALP), alanine amino Transferase (ALT) and aspartate amino transferase (AST). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Change From Baseline in Clinical Chemistry Parameter- ALP, ALT, AST at Week 24 and Week 52 ALT Week 24; n=9, 7	1.0 International Unit (IU)/L Standard Deviation 15.86	5.1 International Unit (IU)/L Standard Deviation 7.56
Change From Baseline in Clinical Chemistry Parameter- ALP, ALT, AST at Week 24 and Week 52 ALT Week 52; n=10, 10	-2.5 International Unit (IU)/L Standard Deviation 11.16	2.1 International Unit (IU)/L Standard Deviation 5.80
Change From Baseline in Clinical Chemistry Parameter- ALP, ALT, AST at Week 24 and Week 52 ALP Week 24; n=9, 7	-16.0 International Unit (IU)/L Standard Deviation 26.14	-5.0 International Unit (IU)/L Standard Deviation 60.03
Change From Baseline in Clinical Chemistry Parameter- ALP, ALT, AST at Week 24 and Week 52 ALP Week 52; n=10, 10	-17.5 International Unit (IU)/L Standard Deviation 35.25	19.9 International Unit (IU)/L Standard Deviation 80.63
Change From Baseline in Clinical Chemistry Parameter- ALP, ALT, AST at Week 24 and Week 52 AST Week 24; n=6, 3	3.2 International Unit (IU)/L Standard Deviation 7.91	7.3 International Unit (IU)/L Standard Deviation 4.04
Change From Baseline in Clinical Chemistry Parameter- ALP, ALT, AST at Week 24 and Week 52 AST Week 52; n=7, 4	3.3 International Unit (IU)/L Standard Deviation 5.68	9.3 International Unit (IU)/L Standard Deviation 3.86

PRIMARY outcome

Timeframe: Baseline, Week 24 and Week 52

Population: mITT Population

Clinical chemistry parameters included direct bilirubin (DB), total bilirubin (TB) and creatinine (C). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Change From Baseline in Clinical Chemistry Parameter- Direct Bilirubin, Total Bilirubin and Creatinine at Week 24 and Week 52 DB Week 24; n=8, 3	0.6 Micromole per Liter (umol/L) Standard Deviation 1.51	-0.7 Micromole per Liter (umol/L) Standard Deviation 3.06
Change From Baseline in Clinical Chemistry Parameter- Direct Bilirubin, Total Bilirubin and Creatinine at Week 24 and Week 52 DB Week 52; n=9, 5	0.9 Micromole per Liter (umol/L) Standard Deviation 1.54	0.2 Micromole per Liter (umol/L) Standard Deviation 1.30
Change From Baseline in Clinical Chemistry Parameter- Direct Bilirubin, Total Bilirubin and Creatinine at Week 24 and Week 52 TB Week 24; n=9, 7	3.0 Micromole per Liter (umol/L) Standard Deviation 6.50	2.7 Micromole per Liter (umol/L) Standard Deviation 5.22
Change From Baseline in Clinical Chemistry Parameter- Direct Bilirubin, Total Bilirubin and Creatinine at Week 24 and Week 52 TB Week 52; n=10, 10	2.9 Micromole per Liter (umol/L) Standard Deviation 5.26	2.9 Micromole per Liter (umol/L) Standard Deviation 3.38
Change From Baseline in Clinical Chemistry Parameter- Direct Bilirubin, Total Bilirubin and Creatinine at Week 24 and Week 52 C Week 24; n=9, 7	-471.1 Micromole per Liter (umol/L) Standard Deviation 317.54	-571.3 Micromole per Liter (umol/L) Standard Deviation 183.53
Change From Baseline in Clinical Chemistry Parameter- Direct Bilirubin, Total Bilirubin and Creatinine at Week 24 and Week 52 C Week 52; n=10, 10	-468.4 Micromole per Liter (umol/L) Standard Deviation 310.54	-609.8 Micromole per Liter (umol/L) Standard Deviation 271.89

PRIMARY outcome

Timeframe: Baseline, Week 24 and Week 52

Population: mITT Population

Clinical chemistry parameters included calcium (Ca), carbon dioxide content/bicarbonate (CO2/Bicar), glucose (Gl), potassium (K), sodium (Na), phosphorus inorganic (PhI), urea/blood urine nitrogen (U/BUN). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 Ca Week 24; n=9, 7	0.116 Millimole (MMOL)/L Standard Deviation 0.1344	0.167 Millimole (MMOL)/L Standard Deviation 0.1942
Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 Ca Week 52; n=10, 9	0.116 Millimole (MMOL)/L Standard Deviation 0.1013	0.128 Millimole (MMOL)/L Standard Deviation 0.1386
Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 CO2/Bicar Week 24; n=7, 6	-3.73 Millimole (MMOL)/L Standard Deviation 5.951	1.70 Millimole (MMOL)/L Standard Deviation 3.449
Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 Na Week 52; n=10, 10	-0.7 Millimole (MMOL)/L Standard Deviation 3.71	2.2 Millimole (MMOL)/L Standard Deviation 4.71
Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 CO2/Bicar Week 52; n=8, 9	-2.68 Millimole (MMOL)/L Standard Deviation 5.142	0.77 Millimole (MMOL)/L Standard Deviation 3.588
Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 Gl Week 24; n=5, 5	0.20 Millimole (MMOL)/L Standard Deviation 3.093	-0.04 Millimole (MMOL)/L Standard Deviation 2.003
Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 Gl Week 52; n=5, 8	-0.32 Millimole (MMOL)/L Standard Deviation 2.483	1.79 Millimole (MMOL)/L Standard Deviation 4.107
Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 K Week 24; n=9, 7	0.06 Millimole (MMOL)/L Standard Deviation 0.723	-0.63 Millimole (MMOL)/L Standard Deviation 0.923
Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 K Week 52; n=10, 10	-0.02 Millimole (MMOL)/L Standard Deviation 0.535	-0.44 Millimole (MMOL)/L Standard Deviation 0.877
Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 Na Week 24; n=9, 7	-0.6 Millimole (MMOL)/L Standard Deviation 4.03	5.9 Millimole (MMOL)/L Standard Deviation 5.01
Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 PhI Week 24; n=8, 7	-0.225 Millimole (MMOL)/L Standard Deviation 0.3843	-0.913 Millimole (MMOL)/L Standard Deviation 0.5862
Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 PhI Week 52; n=9, 9	-0.227 Millimole (MMOL)/L Standard Deviation 0.4234	-0.726 Millimole (MMOL)/L Standard Deviation 0.5453
Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 U/BUN Week 24; n=9, 6	-5.91 Millimole (MMOL)/L Standard Deviation 12.164	-9.47 Millimole (MMOL)/L Standard Deviation 9.128
Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 U/BUN Week 52; n=10, 9	-8.13 Millimole (MMOL)/L Standard Deviation 14.967	-9.01 Millimole (MMOL)/L Standard Deviation 7.323

PRIMARY outcome

Timeframe: Baseline, Week 24 and Week 52

Population: mITT Population

Change from Baseline in GFR was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Change From Baseline in Clinical Chemistry Parameter- Glomerular Filtration Rate (GFR) at Week 24 and Week 52 Week 24; n=9, 7	42.80 milliliter (mL)/Minute (min) Standard Deviation 23.604	44.36 milliliter (mL)/Minute (min) Standard Deviation 10.731
Change From Baseline in Clinical Chemistry Parameter- Glomerular Filtration Rate (GFR) at Week 24 and Week 52 Week 52; n=10, 10	42.33 milliliter (mL)/Minute (min) Standard Deviation 29.140	53.75 milliliter (mL)/Minute (min) Standard Deviation 15.176

PRIMARY outcome

Timeframe: Baseline, Week 24 and Week 52

Population: mITT Population

Change from Baseline in immunoglobulins IgA, IgG and IgM was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 24 and Week 52 IgA Week 24; n=2, 3	-0.500 G/L Standard Deviation 0.2828	-0.433 G/L Standard Deviation 0.6429
Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 24 and Week 52 IgA Week 52; n=2, 3	-0.300 G/L Standard Deviation 0.0000	-0.500 G/L Standard Deviation 0.5292
Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 24 and Week 52 IgG Week 24; n=6, 6	-1.02 G/L Standard Deviation 1.184	-2.40 G/L Standard Deviation 1.731
Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 24 and Week 52 IgG Week 52; n=10, 9	0.78 G/L Standard Deviation 3.595	-2.13 G/L Standard Deviation 1.702
Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 24 and Week 52 IgM Week 24; n=2, 3	-0.100 G/L Standard Deviation 0.0000	-0.133 G/L Standard Deviation 0.3512
Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 24 and Week 52 IgM Week 52; n=2, 3	0.0000 G/L Standard Deviation 0.0000	-0.333 G/L Standard Deviation 0.4933

SECONDARY outcome

Timeframe: Baseline, Week 24 and Week 52

Population: mITT Population

Memory B cells are B cell sub-type that are formed within germinal centres following primary infection and are important in generating an accelerated and more robust antibody-mediated immune response in the case of re-infection. Memory B cell count included CD20+CD27+ cells/mm\^3. Baseline value used in the analysis was of Day 0 (Day of transplant). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Percent change from Baseline in Memory B cell count was calculated as the value at Week 24 and Week 52 minus the value at Baseline multiplied by 100. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Median Difference and 95% confidence interval of difference obtained using the Hodges-Lehmann method.

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Median Percent Change From Baseline in Memory B Cell Count at Week 24 and Week 52 Week 24; n=9, 7	-12.5 Percent change Interval -88.0 to 320.0	177.8 Percent change Interval 40.0 to 800.0
Median Percent Change From Baseline in Memory B Cell Count at Week 24 and Week 52 Week 52; n=10, 7	2.4 Percent change Interval -67.0 to 340.0	-33.3 Percent change Interval -80.0 to 44.0

SECONDARY outcome

Timeframe: Week 24 and Week 52

Population: mITT Population

Activated memory B cell-CD95% count is CD19+CD27+CD95 conc-cells/mL. Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Activated Memory B Cells Count at Week 24 and Week 52 Week 24; n=9, 7	37157.2 cells/mL Standard Error 16664.42	38389.6 cells/mL Standard Error 18682.83
Activated Memory B Cells Count at Week 24 and Week 52 Week 52; n=10, 8	24220.8 cells/mL Standard Error 15744.17	11092.5 cells/mL Standard Error 17711.36

SECONDARY outcome

Timeframe: Week 24 and Week 52

Population: mITT Population

Activated memory B cell-CD95% percentage is CD19+CD27+CD95+ (%CD19/CD27). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Activated Memory B Cells Percentage at Week 24 and Week 52 Week 24; n=9, 7	32.8 Percentage of activated memory B cells Standard Error 5.94	19.0 Percentage of activated memory B cells Standard Error 6.06
Activated Memory B Cells Percentage at Week 24 and Week 52 Week 52; n=11, 10	32.0 Percentage of activated memory B cells Standard Error 5.07	38.8 Percentage of activated memory B cells Standard Error 5.48

SECONDARY outcome

Timeframe: Week 24 and Week 52

Population: mITT Population

Transitional B cell count (Newell) is CD19+CD24b+CD38b+IgD+ (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Transitional B Cells Count at Week 24 and Week 52 Week 24; n=9, 7	5470 cells/mL Standard Error 2910.9	2679 cells/mL Standard Error 3518.4
Transitional B Cells Count at Week 24 and Week 52 Week 52; n=10, 8	7110 cells/mL Standard Error 2836.7	6652 cells/mL Standard Error 3291.5

SECONDARY outcome

Timeframe: Week 24 and Week 52

Population: mITT Population

Transitional B cell percentage (Newell) is CD19+CD24b+CD38b+IgD+ (%CD19+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Transitional B Cells Percentage at Week 24 and Week 52 Week 24; n=9, 7	2.43 Percentage of transitional B cells Standard Error 0.776	1.14 Percentage of transitional B cells Standard Error 0.869
Transitional B Cells Percentage at Week 24 and Week 52 Week 52; n=11, 10	2.61 Percentage of transitional B cells Standard Error 0.713	3.41 Percentage of transitional B cells Standard Error 0.731

SECONDARY outcome

Timeframe: Week 24 and Week 52

Population: mITT Population

A T cell is a type of lymphocyte that plays a central role in cell-mediated immunity. Activated T cell count Codarri is CD4+ CD25hi CD45RA- IL 7Rhi (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Activated T Cell Count at Week 24 and Week 52 Week 24; n=9, 6	109279.5 cells/mL Standard Error 22998.02	78952.7 cells/mL Standard Error 26155.19
Activated T Cell Count at Week 24 and Week 52 Week 52; n=10, 7	122304.7 cells/mL Standard Error 21898.24	75349.4 cells/mL Standard Error 24313.62

SECONDARY outcome

Timeframe: Week 24 and Week 52

Population: mITT Population

Activated T cell percentage (Codarri)= CD4+ CD25hi CD45RA- IL 7Rhi (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Activated T Cell Percentage at Week 24 and Week 52 Week 24; n=9, 6	17.0 Percentage of activated T cell Standard Error 2.29	14.0 Percentage of activated T cell Standard Error 2.58
Activated T Cell Percentage at Week 24 and Week 52 Week 52; n=10, 7	15.2 Percentage of activated T cell Standard Error 2.15	14.7 Percentage of activated T cell Standard Error 2.33

SECONDARY outcome

Timeframe: Week 24 and Week 52

Population: mITT Population

Regulatory T cell count is CD4+ CD25hi IL-7Rlo (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Regulatory T Cell Count at Week 24 and Week 52 Week 24; n= 9, 7	23586.2 cells/mL Standard Error 8427.77	24234.5 cells/mL Standard Error 9238.41
Regulatory T Cell Count at Week 24 and Week 52 Week 52; n= 10, 8	33038.7 cells/mL Standard Error 7676.99	27419.8 cells/mL Standard Error 9093.84

SECONDARY outcome

Timeframe: Week 24 and Week 52

Population: mITT Population

Regulatory T cell (%CD4) = CD4+ CD25hi IL-7Rlo (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Regulatory T Cell (%CD4) at Week 24 and Week 52 Week 52; n= 11, 10	5.0 Percentage of Regulatory T cell Standard Error 1.01	4.4 Percentage of Regulatory T cell Standard Error 1.04
Regulatory T Cell (%CD4) at Week 24 and Week 52 Week 24; n= 9, 7	4.4 Percentage of Regulatory T cell Standard Error 1.12	4.6 Percentage of Regulatory T cell Standard Error 1.25

SECONDARY outcome

Timeframe: Week 24 and Week 52

Population: mITT Population

Activated: regulatory T cell ratio is Activated T cell CD4+CD25hi CD45RA IL 7Rhi (absolute number)/ Regulatory T cell CD4+CD25hi CD45RA IL 7Rlo (absolute number). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Mean Activated: Regulatory T Cell Ratio at Week 24 and Week 52 Week 24; n= 9, 6	4.88 Ratio Standard Error 0.832	3.33 Ratio Standard Error 0.915
Mean Activated: Regulatory T Cell Ratio at Week 24 and Week 52 Week 52; n= 10, 7	4.62 Ratio Standard Error 0.779	3.61 Ratio Standard Error 0.942

SECONDARY outcome

Timeframe: Week 24 and Week 52

Population: mITT Population. Participants analyzed had at least one biopsy.

The endpoint diagnosis was made by a proven biopsy result. Number of rejections only counted once per participant. The proportion of participants with episodes of acute rejection was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Proportion of Participants With Episodes of Acute Rejection at Week 24 and Week 52 Week 52; n=5, 6	0.6 Proportion of participants	0.33 Proportion of participants
Proportion of Participants With Episodes of Acute Rejection at Week 24 and Week 52 Week 24; n=5, 6	0.4 Proportion of participants	0.33 Proportion of participants

SECONDARY outcome

Timeframe: Week 24 and Week 52

Population: mITT Population

Adjusted mean difference for serum creatinine values (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction, at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Mean Serum Creatinine at Week 24 and Week 52 Week 24; n=9, 7	115.1 micromole/L Standard Error 35.24	112.3 micromole/L Standard Error 38.20
Mean Serum Creatinine at Week 24 and Week 52 Week 52; n= 10, 10	135.4 micromole/L Standard Error 33.50	122.6 micromole/L Standard Error 33.37

SECONDARY outcome

Timeframe: Week 24 and Week 52

Population: mITT Population

The estimated glomerular filtration rate (eGFR) were calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation. Adjusted mean difference(treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the indicated time points were analyzed (represented by n= X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Mean eGFR at Week 24 and Week 52 Week 24; n=9, 7	62.25 mL/minute/1.73 square meter (m^2) Standard Error 6.119	49.33 mL/minute/1.73 square meter (m^2) Standard Error 6.897
Mean eGFR at Week 24 and Week 52 Week 52; n= 10, 10	58.99 mL/minute/1.73 square meter (m^2) Standard Error 5.732	56.29 mL/minute/1.73 square meter (m^2) Standard Error 5.765

SECONDARY outcome

Timeframe: Week 24

Population: mITT Population

Adjusted mean difference (treatment-placebo) for Prednisolone use and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments Only those participants available at indicated timepoints were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=7 Participants Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Mean Prednisolone Use at Week 24	5.71 mg/day Standard Error 1.438	5.27 mg/day Standard Error 1.713

Adverse Events

Placebo

Serious events: 7 serious events

Other events: 9 other events

Deaths: 0 deaths

Belimumab 10mg/kg

Serious events: 5 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=13 participants at risk Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.	Belimumab 10mg/kg n=12 participants at risk Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Cardiac disorders Acute myocardial infarction	7.7% 1/13 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Investigations Alanine aminotransferase increased	7.7% 1/13 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Blood and lymphatic system disorders Anaemia	7.7% 1/13 • Number of events 3 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Investigations Blood creatinine increased	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Cardiac disorders Cardiac failure acute	7.7% 1/13 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Infections and infestations Cellulitis	7.7% 1/13 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Infections and infestations Clostridium difficile colitis	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Gastrointestinal disorders Colitis	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Metabolism and nutrition disorders Dehydration	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Psychiatric disorders Delirium	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Gastrointestinal disorders Diarrhoea	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Infections and infestations Escherichia urinary tract infection	7.7% 1/13 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Renal and urinary disorders Focal segmental glomerulosclerosis	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Renal and urinary disorders Glomerulonephritis	7.7% 1/13 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Injury, poisoning and procedural complications Hip fracture	7.7% 1/13 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Vascular disorders Lymphocele	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Infections and infestations Pneumonia	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	7.7% 1/13 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Infections and infestations Renal cyst infection	7.7% 1/13 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Infections and infestations Tonsillitis	7.7% 1/13 • Number of events 2 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Immune system disorders Transplant rejection	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Infections and infestations Urinary tract infection	7.7% 1/13 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	0.00% 0/12 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Infections and infestations Urosepsis	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.
Infections and infestations Wound infection	0.00% 0/13 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.	8.3% 1/12 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks). On-treatment SAEs and non-serious AEs are reported for MITT Population.