Phase 4 Completed N=27 Randomized Treatment

Belatacept 3 Month Post Transplant Conversion Study

Transplant; Failure, Kidney · EBV

Source: ClinicalTrials.gov NCT02213068 ↗

Enrolled (actual)

Serious AEs

7.4%

Results posted

Sep 2021

Primary outcomePrimary: Change in eGFR (MDRD) at 2 Years Post-transplant Compared to Baseline at Month 3 (Conversion) — -5.44; 8.08; -0.38 mL/min/1.73m2

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months after kidney transplantation. The immune system is the body's defense against infection and other disease. After transplantation, the body sees the new organ as "foreign" and tries to destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from attacking the transplanted organ. The primary purpose of this research study is to evaluate the effects of three (3) different immunosuppressive treatments on rejection in post-transplant kidney recipients. This study will test whether switching from tacrolimus to belatacept will improve long-term kidney function. Three of the immunosuppressants used in this study- mycophenolic acid (MPA), mycophenolate mofetil (MMF) and tacrolimus- are medications approved by the United States Food and Drug Administration (FDA) to be used after transplant. All of these medications have been routinely used in kidney recipients here at Northwestern University. Belatacept (the "study drug") has been approved by the FDA for use at the time of transplant. However, the use of belatacept in this study is considered investigational as it has not been FDA approved for use beginning at 3 months after transplant. This study will involve 51 adult kidney transplant recipients at Northwestern.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in eGFR (MDRD) at 2 Years Post-transplant Compared to Baseline at Month 3 (Conversion)	-5.44; 8.08; -0.38	—
PRIMARY Acute Rejection	4; 0; 2	—
PRIMARY Graft Survival	8; 8; 10	—
PRIMARY Patient Survival	9; 7; 9	—

Eligibility Criteria

Inclusion Criteria

Adult ≥ 18 years of age
Male or Female
EBV seropositive
Recipient of renal transplant from living or deceased donor

Exclusion Criteria

Recipients with EBV serostatus negative or unknown
History of acute rejection (AR) within 3 months prior to randomization
History of positive donor specific antibodies (DSA)
History of antibody mediated rejection
Positive T-cell lymphocytotoxic cross match
Proteinuria >1 g/day or > 0.5 g/day if diabetic
Rejection on 3 month post-transplant screening biopsy
BK nephropathy at 3 months post-transplant screening biopsy
Positive pregnancy test at the time of randomization in female of child bearing potential
History of previous transplant

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02213068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.