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Belatacept Conversion in Proteinuric Kidney Transplant Recipients

Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Proteinuria; Kidney Transplantation; Belatacept

Intervention: Belatacept (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Brigham and Women's Hospital

Summary

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.

Clinical Details

Official title: The B7-1 Study": Belatacept Conversion in Proteinuric Renal Transplant Recipients and B7-1 Positivity Status on Biopsy: an Interventional Multi-Center Trial

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Proteinuria by 25%

Secondary outcome:

Percent change of renal function (Creatinine in mg/dl and eGFR in ml/min)

Change in number and mean-fluoroscence intensity of donor-specific anti-HLA antibodies (DSA)

Correlation of B7-1 positivity on immunofluorescence on biopsy (grade 1-3) with B7-1-expression in urine extracellular vesicles (mean-fluoroscence intensity)

Acute rejection episodes

Change in Blood pressure measurement (mm Hg)

New onset diabetes

Hyperlipidemia

Graft survival

Patient survival

Detailed description: A total of 36 patients will be recruited.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Male or female adult kidney transplant recipients older than 18 years old 2. eGFR ≥30 ml/min 3. ≥6 months after transplantation 4. Proteinuria ≥1 gram/day in spot urine protein/creatinine ratio 5. Available biopsy specimen for B7-1 staining at recruitment time. 6. Ability to provide written informed consent for the study. 7. Maintenance immunosuppression of CNI (cyclosporine or tacrolimus), antiproliferative agent (azathioprine, MMF or MPA) with either steroids or not. Exclusion Criteria: 1. Age <18 years 2. eGFR<30 ml/min 3. active acute cellular rejection (ACR; higher than borderline) or ACR in the previous 6 months; active acute antibody-mediated rejection 4. recurrent FSGS 5. EBV IgG negative 6. patient on mTOR inhibitor (e. g. Everolimus, Sirolimus) 7. patient only on CNI (cyclosporine or tacrolimus) and steroids

Locations and Contacts

Additional Information

Starting date: March 2015
Last updated: December 24, 2014

Page last updated: August 23, 2015

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