Trial Outcomes & Findings for Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant (NCT NCT00596947)

Last Updated: 2017-05-15

Results Overview

Acute rejection episodes would have been measured by the number of participants who underwent a kidney transplant biopsy, and had the results of the biopsy reported as acute rejection by the transplant pathologist. Biopsies were only performed if clinically indicated. The cumulative number of participants with recorded rejection episodes by 6 and 12 months post-transplant would have been reported.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

18 participants

Primary outcome timeframe

6 and 12 months post-transplant

Results posted on

2017-05-15

Participant Flow

Study was terminated early due to low enrollment.

Participant milestones

Participant milestones
Measure	Prednisone Withdrawal Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.	Prednisone Maintenance Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
Overall Study STARTED	9	9
Overall Study COMPLETED	3	6
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Prednisone Withdrawal Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.	Prednisone Maintenance Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
Overall Study study halted due to low enrollment	5	3
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prednisone Withdrawal n=9 Participants Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.	Prednisone Maintenance n=9 Participants Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=93 Participants	9 Participants n=4 Participants	18 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	47.5 years STANDARD_DEVIATION 12.3 • n=93 Participants	50.6 years STANDARD_DEVIATION 13.2 • n=4 Participants	49.2 years STANDARD_DEVIATION 12.5 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	5 Participants n=4 Participants	14 Participants n=27 Participants
Region of Enrollment United States	9 participants n=93 Participants	9 participants n=4 Participants	18 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 and 12 months post-transplant

Population: data not interpretable due to low patient enrollment

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 and 12 months

Population: data not interpretable due to low patient enrollment

The number of participants who did not experience graft failure (defined as return to dialysis) at 6 and 12 months would have been reported.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 and 12 months

Population: data not interpretable due to low patient enrollment

The number of participants alive at 6 and 12 months post-transplant would have been posted as a measure of patient survival.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Unable to interpret data due to low number of patients enrolled.

This measure was defined as the percentage of participants that did not remain on initial therapy (ie were withdrawn from each arm of the trial)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: unable to interpret results due to low number of patients enrolled.

The length of the hospital stay would have assessed the number of days a participant was in the hospital after the kidney transplant was performed. This is calculated from date of admission to date of discharge.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Unable to interpret data due to low number of patients enrolled.

The number of readmissions during the study period for each participant would have been assessed, as well as the reason for readmissions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Unable to interpret data due to low number of patients enrolled.

The time from admission to discharge for each readmission for patients readmitted in the first 12 months post-transplant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3, 6 and 12 months

Population: Unable to interpret data due to low number of patients enrolled.

The above methods focus on estimating or determining actual glomerular filtration rate (GFR) (or renal function) of the kidney transplant. The MDRD (Modification of Diet in Renal Disease) calculation includes age, sex and serum creatinine would have provided an estimate of GFR. This was to be performed at 3,6 and 12 months post-transplant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 and 12 months post-transplant

Population: Unable to interpret data due to low number of patients enrolled.

Results would have been reported from patients undergoing 24 hour urine collections at 3 and 12 months post-transplant. This is a way to measure glomerular function rate (GFR) or renal function.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: unable to interpret results due to low number of patients enrolled.

The incidence and severity of rejection episodes per participant would have been identified by kidney transplant biopsy results read by a transplant pathologist. Treatment of rejection episodes in each participant would have been determined by the treating transplant physician.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: unable to interpret results due to low number of patients enrolled.

All participants would have been assessed for the presence at any time during the trial of: leukopenia (defined by lab results as a white count less than 3,000 cells/uL).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Unable to interpret data due to low number of patients enrolled.

Participants would have been monitored throughout the study for any infectious complications as confirmed by the principal investigator. Patients would have been monitored by urine cytology and blood polymerase chain reaction for BK virus at baseline, and months 3, 6 and 12 post-transplant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Unable to interpret data due to low number of patients enrolled.

Participants would have been monitored throughout the study with any reports of malignancy being confirmed by principal investigator.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: unable to interpret results due to low number of patients enrolled.

The number of participants who developed hypertension defined as blood pressure greater than 140/90 throughout the first 12 months of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Unable to interpret data due to low number of patients enrolled.

Fasting lipid profiles were to be performed at 3,6 and 12 months post-transplant. Definitions based on ATP III guidelines.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline (within 1 month post-transplant), 3, 6, 12 and 24 months

Population: unable to interpret results due to low number of patients enrolled.

Bone densitometry by Computed tomography of peripheral skeleton and DEXA scans were performed at baseline (within one month after transplant) Urine and blood samples to measure markers of bone turnover: Alkaline phosphatase, pyridinoline, serum 1-25 vit D 3 levels (calcitriol) and 25 hydroxy vit D (calcidiol) levels and serum osteocalcin levels were drawn at baseline, 3, 6, 12 and 24 months.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre-transplant in living donor recipients, baseline (within one month post-transplant) and at 3, 6 and 12 months

Population: unable to interpret results due to low number of patients enrolled.

Glucose tolerance test performed in non-diabetic participants only at pre transplant in living donor recipients and at baseline (within 1 mo after transplant) and 6 mo and 12 months. Blood test for hemoglobin A1C in non diabetic participants only: at baseline, 3, 6, and 12 months. Insulin and C peptide levels at baseline, 3,6 and 12 months in all participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: unable to interpret results due to low number of patients enrolled.

Height, weight will be used to calculate change in BMI for all participants.

Outcome measures

Outcome data not reported

Adverse Events

Prednisone Withdrawal

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Prednisone Maintenance

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Prednisone Withdrawal n=9 participants at risk Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.	Prednisone Maintenance n=9 participants at risk Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
Vascular disorders gangrene	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 2 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Renal and urinary disorders lower extremity edema	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Cardiac disorders shortness of breath	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Renal and urinary disorders hyperkalemia	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Infections and infestations cytomegalovirus	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) post transplant lymphoproliferative disorder	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Injury, poisoning and procedural complications lymphocele	22.2% 2/9 • Number of events 2 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Surgical and medical procedures perinephric fluid collection	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
General disorders fever	22.2% 2/9 • Number of events 2 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Endocrine disorders hyperglycemia	11.1% 1/9 • Number of events 2 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Immune system disorders acute cellular rejection	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) basal cell carcinoma	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Nervous system disorders seizure	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Cardiac disorders 3 Vessel CABG	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.

Other adverse events

Additional Information

Jennifer Trofe-Clark, Clinical Transplant Research Pharmacist

Hospital of the University of Pennsylvania

Phone: 215-614-4274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Prednisone Withdrawal n=9 participants at risk Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.	Prednisone Maintenance n=9 participants at risk Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
Surgical and medical procedures wound drainage	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Infections and infestations urinary tract infection	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Infections and infestations fungal infection of toes	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Renal and urinary disorders lower extremity edema	22.2% 2/9 • Number of events 3 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	22.2% 2/9 • Number of events 4 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
General disorders fatigue	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Cardiac disorders shortness of breath	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Cardiac disorders lightheadedness	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Renal and urinary disorders hypertension	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
General disorders pain in right calf	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Psychiatric disorders depression	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Renal and urinary disorders hyperkalemia	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	22.2% 2/9 • Number of events 4 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Renal and urinary disorders increased serum creatinine	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	22.2% 2/9 • Number of events 2 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Blood and lymphatic system disorders leukopenia	22.2% 2/9 • Number of events 5 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	33.3% 3/9 • Number of events 4 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Metabolism and nutrition disorders recurrence of gout	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Injury, poisoning and procedural complications increased tacrolimus trough level	33.3% 3/9 • Number of events 3 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Endocrine disorders hyperglycemia	22.2% 2/9 • Number of events 2 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	22.2% 2/9 • Number of events 2 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Renal and urinary disorders hypophosphatemia	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Injury, poisoning and procedural complications hand tremors related to tacrolimus therapy	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Blood and lymphatic system disorders lymphocele	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	22.2% 2/9 • Number of events 2 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Injury, poisoning and procedural complications reaccumulation of peritransplant fluid collection	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Gastrointestinal disorders diarrhea	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	22.2% 2/9 • Number of events 4 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Respiratory, thoracic and mediastinal disorders seasonal allergies	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Renal and urinary disorders anemia	22.2% 2/9 • Number of events 2 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	22.2% 2/9 • Number of events 2 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Metabolism and nutrition disorders osteopenia	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	22.2% 2/9 • Number of events 2 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Gastrointestinal disorders vomiting	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Metabolism and nutrition disorders osteoporosis	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Gastrointestinal disorders constipation	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Blood and lymphatic system disorders increased hemoglobin	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Infections and infestations bronchitis	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Skin and subcutaneous tissue disorders blister	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
General disorders insomnia	22.2% 2/9 • Number of events 2 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Renal and urinary disorders hypokalemia	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Renal and urinary disorders hypercalcemia	22.2% 2/9 • Number of events 2 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Renal and urinary disorders hypocalcemia	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Musculoskeletal and connective tissue disorders leg cramps	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
General disorders headache every morning	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Renal and urinary disorders nocturia	11.1% 1/9 • Number of events 1 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.	0.00% 0/9 • up to 24 months post-transplant Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.