Trial Outcomes & Findings for Belatacept Conversion in Proteinuric Kidney Transplant Recipients (NCT NCT02327403)

Results Overview

Change in proteinuria by 25%: daily proteinuria is estimated by spot urine protein (mg/dL) to creatinine (mg/dL) ratio at baseline (before the belatacept conversion) and post-conversion 12 months; and interval % change was calculated by getting the ratio of difference between the two time points to the baseline value.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

12 months

Results posted on

2022-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	Belatacept Conversion Kidney Transplant recipients with proteinuria who converted their immunosuppression from CNI to belatacept-based maintenance therapy
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Belatacept Conversion in Proteinuric Kidney Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belatacept Conversion n=15 Participants Belatacept: Conversion from calcineurin-inhibitor to Belatacept maintenance immunosuppression.
Age, Continuous	57 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Black	3 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · White	7 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	3 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Change in proteinuria by 25%: daily proteinuria is estimated by spot urine protein (mg/dL) to creatinine (mg/dL) ratio at baseline (before the belatacept conversion) and post-conversion 12 months; and interval % change was calculated by getting the ratio of difference between the two time points to the baseline value.

Outcome measures

Outcome measures
Measure	Belatacept Conversion n=13 Participants Belatacept: Conversion from calcineurin-inhibitor to Belatacept maintenance immunosuppression.
Change in Proteinuria by 25%	8 Participants

SECONDARY outcome

Timeframe: from baseline to 12 months

Outcome measures

Outcome measures
Measure	Belatacept Conversion n=13 Participants Belatacept: Conversion from calcineurin-inhibitor to Belatacept maintenance immunosuppression.
Change in Renal Function (eGFR in mL/Min/1.73 m^2) Baseline	45.8 mL/min/1.73m2 Standard Deviation 13.3
Change in Renal Function (eGFR in mL/Min/1.73 m^2) 12 Months	45.1 mL/min/1.73m2 Standard Deviation 12.7

SECONDARY outcome

Timeframe: 12 months

Acute rejection episodes \[Time Frame: 12 months\]: Number of biopsy-proven rejection episodes from belatacept conversion to post-conversion 12 months.

Outcome measures

Outcome measures
Measure	Belatacept Conversion n=13 Participants Belatacept: Conversion from calcineurin-inhibitor to Belatacept maintenance immunosuppression.
Acute Rejection Episodes	0 episodes

SECONDARY outcome

Timeframe: 12 months

Change in Blood pressure measurement (mm Hg) \[Time Frame: 12 months\]: The mmHg difference in systolic and diastolic blood pressures between the baseline (pre-belatacept conversion) and post-conversion 12 months is assessed. Blood pressure measurement done at the office visits at baseline and 12 months after at least 5 minutes of resting.

Outcome measures

Outcome measures
Measure	Belatacept Conversion n=13 Participants Belatacept: Conversion from calcineurin-inhibitor to Belatacept maintenance immunosuppression.
Change in Blood Pressure Measurement (mm Hg) Baseline (Systolic)	140 mmHg Standard Deviation 11
Change in Blood Pressure Measurement (mm Hg) Baseline (Diastolic)	76 mmHg Standard Deviation 6
Change in Blood Pressure Measurement (mm Hg) 12 Months (Systolic)	129 mmHg Standard Deviation 16
Change in Blood Pressure Measurement (mm Hg) 12 Months (Diastolic)	72 mmHg Standard Deviation 9

SECONDARY outcome

Timeframe: 12 months

New onset diabetes \[Time Frame: 12 months\]: Number of new onset diabetes per American Diabetes Association 2015 Criteria from belatacept conversion to post-conversion 12 months

Outcome measures

Outcome measures
Measure	Belatacept Conversion n=13 Participants Belatacept: Conversion from calcineurin-inhibitor to Belatacept maintenance immunosuppression.
Change in Fasting Glucose Baseline	119 mg/dL Standard Deviation 37
Change in Fasting Glucose 12 Months	124 mg/dL Standard Deviation 62

SECONDARY outcome

Timeframe: 12 months

Hyperlipidemia \[ Time Frame: 12 months\]: Changes (mg/dL) in serum total cholesterol, LDL, HDL, and triglyceride levels from pre-belatacept conversion to post-conversion 12 months.

Outcome measures

Outcome measures
Measure	Belatacept Conversion n=13 Participants Belatacept: Conversion from calcineurin-inhibitor to Belatacept maintenance immunosuppression.
Hyperlipidemia Baseline Total Cholesterol	177 mg/dL Standard Deviation 49
Hyperlipidemia 12 Month Total Cholesterol	171 mg/dL Standard Deviation 49

SECONDARY outcome

Timeframe: 12 months

Graft survival \[Time Frame: 12 months\]: Number of patients who developed end stage kidney disease and required kidney replacement therapy within 12 months post-belatacept conversion.

Outcome measures

Outcome measures
Measure	Belatacept Conversion n=13 Participants Belatacept: Conversion from calcineurin-inhibitor to Belatacept maintenance immunosuppression.
Graft Survival	13 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Belatacept Conversion n=15 Participants Belatacept: Conversion from calcineurin-inhibitor to Belatacept maintenance immunosuppression.
Patient Survival	14 Participants

Adverse Events

Belatacept Conversion

Serious events: 1 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Belatacept Conversion n=15 participants at risk Kidney Transplant recipients with proteinuria who converted their immunosuppression from CNI to belatacept-based maintenance therapy
Cardiac disorders Cardiac Arrest	6.7% 1/15 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure	Belatacept Conversion n=15 participants at risk Kidney Transplant recipients with proteinuria who converted their immunosuppression from CNI to belatacept-based maintenance therapy
Infections and infestations Pneumonia	13.3% 2/15 • Number of events 2 • 1 year
Infections and infestations Shingles	6.7% 1/15 • Number of events 1 • 1 year
Infections and infestations MRSA Cellulitis with Abscess	6.7% 1/15 • Number of events 1 • 1 year
Infections and infestations Cellulitis	6.7% 1/15 • Number of events 1 • 1 year
Infections and infestations Pyelonephritis	6.7% 1/15 • Number of events 1 • 1 year
Infections and infestations Urinary Tract Infection	6.7% 1/15 • Number of events 1 • 1 year
Renal and urinary disorders Acute Kidney Injury	6.7% 1/15 • Number of events 1 • 1 year
Nervous system disorders Syncope	6.7% 1/15 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders Basal Cell Carcinoma	6.7% 1/15 • Number of events 1 • 1 year
Renal and urinary disorders Recurrence of Bladder Tumor	6.7% 1/15 • Number of events 1 • 1 year
Metabolism and nutrition disorders Hypophosphatemia	6.7% 1/15 • Number of events 1 • 1 year

Additional Information

Dr. Leonardo V Riella, MD, PhD

Massachusetts General Hospital

Phone: 6176436266

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place