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Immunosuppressant

Belatacept for Delayed Graft Function

Phase 2
Waitlist Available
Led By Vinay Nair, D.O.
Research Sponsored by Nair, Vinay, D.O.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

The purpose of this study is to evaluate the safety and efficacy of conversion from a calcineurin inhibitor (tacrolimus or cyclosporine) immunosuppression therapy to Nulojix® (belatacept) immunosuppression therapy in patients with delayed (DGF) or slow graft function (SGF) following kidney transplantation. Patients at risk for SGF or DGF will be consented at the time of kidney transplantation. On post-op Day 5 the patient will be assessed, if they have developed SGF or DGF they will be randomized to convert to Belatacept or continue on their CNI regimen. Up to 20 subjects who do not develop DGF will be followed as control subjects. Seventy randomized subjects will be followed for a total of 14 months with a renal biopsy at Month 12 post transplant. Research Hypotheses: Primary Hypotheses: Kidneys with slow or delayed graft function are more susceptible to acute and long-term CNI toxicity Kidneys converted from calcineurin inhibitor based therapy to belatacept will achieve a more rapid recovery from post-ischemic acute tubular necrosis (ATN) and will have improved 1 year calculated GFR. Key Secondary Hypotheses: Renal Histology: Belatacept converted patients will have a lower chronic allograft damage index (CADI) score and lower interstitial fibrosis and tubular atrophy (IF/TA) score as calculated by Banff criteria at 1 year post- transplant Biomarker Analysis: Biomarker analysis (clusterin) measured in serial urine collections can 1) directly assess CNI induced kidney injury and 2) improve the prediction of patients that benefit in early belatacept conversion.

Eligible Conditions
  • Delayed Graft Function
  • Kidney Transplant

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
cGFR
Secondary outcome measures
Biomarker profile
Blood Pressure Control
Duration of Delayed (or slow) Graft Function
+6 more

Side effects data

From 2016 Phase 4 trial • 3 Patients • NCT02078193
67%
COPD exacerbation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BelataceptExperimental Treatment1 Intervention
Subjects will be converted from standard of care CNI therapy to Belatacept 10 mg/kg IV on post renal transplant Day 7 (+/- 3 days). As suggested in the package insert for de novo dosing, further dosing of belatacept will be given as 10 mg/kg IV at weeks 2, 4, 8 and 12 then 5 mg/kg at week 16 and then every 4 weeks (+/- 5 days) through week 52. CNI will be stopped during the first belatacept infusion.
Group II: Calcineurin InhibitorActive Control1 Intervention
Patients randomized to this arm will remain on the current CNI as prescribed by post-transplant standard of care therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belatacept
FDA approved

Find a Location

Who is running the clinical trial?

Nair, Vinay, D.O.Lead Sponsor
Icahn School of Medicine at Mount SinaiOTHER
858 Previous Clinical Trials
524,196 Total Patients Enrolled
1 Trials studying Delayed Graft Function
21 Patients Enrolled for Delayed Graft Function
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,424 Total Patients Enrolled
2 Trials studying Delayed Graft Function
8 Patients Enrolled for Delayed Graft Function

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~8 spots leftby Apr 2025