A Phase 2 interventional study of Belatacept in Proteinuria, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-09.
Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment
Background: Proteinuria develops in about 30% of kidney transplant recipients and is a strong predictor of graft loss. The amount of proteinuria has a direct correlation with the risk of graft failure. Novel therapies are urgently needed to reduce proteinuria and prevent graft loss in transplant recipients, since ACE inhibitors carry a number of limitations in the transplant setting, including significant reduction in renal function, anemia and hyperkalemia.
Preliminary data: B7-1 is expressed at significant levels in about 10% of kidney allograft biopsies with predominance in patients with proteinuria.
Hypothesis: We hypothesize that B7-1 targeting therapy may reduce proteinuria and improve graft survival in proteinuric transplant recipients that have B7-1 staining on allografts. In addition, the absence of CNI nephrotoxicity and the potential protective effect of Belatacept on DSA production may be of benefit in this subset of transplant patients.
Objectives:
Primary: Determine the effect of Belatacept conversion in reducing proteinuria by 25% at 12 months in renal transplant recipients (≥1gram/d) that are either B7-1-positive or negative on kidney biopsy.
Secondary: Assess the effect of Belatacept conversion in the percent change of renal function from baseline to 12 months; donor-specific anti-HLA antibodies presence and intensity (MFI); correlation of B7-1 positivity on immunofluorescence on biopsy with B7-1-expression in urine extracellular vesicles; adverse events; acute rejection episodes; blood pressure control; new onset diabetes; hyperlipidemia; graft survival; and patient survival.
A total of 36 patients will be recruited.
242 studies on the registry are indexed under Proteinuria; 44 are open to participants now.
This study's enrollment of 15 is below the median of 60 across 169 interventional studies indexed under Proteinuria.
Browse Proteinuria studies →Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Exclusion Criteria:
Belatacept conversion
Drug: Belatacept
Conversion from calcineurin-inhibitor to Belatacept maintenance immunosuppression.
Change in Proteinuria by 25%
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.
Time frame: 12 months
Change in Renal Function (eGFR in mL/Min/1.73 m^2)
Time frame: from baseline to 12 months
Acute Rejection Episodes
Acute rejection episodes \[Time Frame: 12 months\]: Number of biopsy-proven rejection episodes from belatacept conversion to post-conversion 12 months.
Time frame: 12 months
Change in Blood Pressure Measurement (mm Hg)
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.
Time frame: 12 months
Change in Fasting Glucose
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
Time frame: 12 months
Hyperlipidemia
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.
Time frame: 12 months
Graft Survival
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.
Time frame: 12 months
Patient Survival
Time frame: 12 months
| Milestone | Belatacept Conversion |
|---|---|
| Started | 15 |
| Completed | 13 |
| Not completed | 2 |
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.
| Participants | Belatacept Conversion |
|---|---|
| Change in Proteinuria by 25% | 8 |
| mL/min/1.73m2 | Belatacept Conversion |
|---|---|
| Baseline | 45.8 ± 13.3 |
| 12 Months | 45.1 ± 12.7 |
Acute rejection episodes \[Time Frame: 12 months\]: Number of biopsy-proven rejection episodes from belatacept conversion to post-conversion 12 months.
| episodes | Belatacept Conversion |
|---|---|
| Acute Rejection Episodes | 0 |
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.
| mmHg | Belatacept Conversion |
|---|---|
| Baseline (Systolic) | 140 ± 11 |
| Baseline (Diastolic) | 76 ± 6 |
| 12 Months (Systolic) | 129 ± 16 |
| 12 Months (Diastolic) | 72 ± 9 |
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
| mg/dL | Belatacept Conversion |
|---|---|
| Baseline | 119 ± 37 |
| 12 Months | 124 ± 62 |
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.
| mg/dL | Belatacept Conversion |
|---|---|
| Baseline Total Cholesterol | 177 ± 49 |
| 12 Month Total Cholesterol | 171 ± 49 |
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.
| Participants | Belatacept Conversion |
|---|---|
| Graft Survival | 13 |
| Participants | Belatacept Conversion |
|---|---|
| Patient Survival | 14 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Belatacept Conversion | 1/15 (6.7%) | 1/15 (6.7%) | 9/15 (60%) |
| Event | Belatacept Conversion |
|---|---|
| Cardiac ArrestCardiac disorders | 1/15 |
| Event | Belatacept Conversion |
|---|---|
| PneumoniaInfections and infestations | 2/15 |
| ShinglesInfections and infestations | 1/15 |
| MRSA Cellulitis with AbscessInfections and infestations | 1/15 |
| CellulitisInfections and infestations | 1/15 |
| PyelonephritisInfections and infestations | 1/15 |
| Urinary Tract InfectionInfections and infestations | 1/15 |
| Acute Kidney InjuryRenal and urinary disorders | 1/15 |
| SyncopeNervous system disorders | 1/15 |
| Basal Cell CarcinomaSkin and subcutaneous tissue disorders | 1/15 |
| Recurrence of Bladder TumorRenal and urinary disorders | 1/15 |
| Age, Continuous(years) | Belatacept Conversion |
|---|---|
| Mean | 57 ± 12 |
| Sex: Female, Male(Participants) | Belatacept Conversion |
|---|---|
| Female | 2 |
| Male | 13 |
| Race/Ethnicity, Customized(Participants) | Belatacept Conversion |
|---|---|
| Ethnicity — Black | 3 |
| Ethnicity — White | 7 |
| Ethnicity — Asian | 2 |
| Ethnicity — Hispanic | 3 |
| Region of Enrollment(participants) | Belatacept Conversion |
|---|---|
| United States | 15 |
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