← Back to Search

Immunosuppressant

Carfilzomib + Belatacept for Kidney Transplant Compatibility (ADAPT Trial)

Phase 1 & 2

Recruiting

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must be able to understand and provide informed consent

UNOS listed for a kidney transplant with specific cPRA criteria

Must not have

Risk-increasing medications

Organ transplant history

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (visit 0), weeks 16, 24, and 52 post treatment initiation

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether two drugs can make people less sensitized to kidney donors, making it easier to find a compatible donor.

Who is the study for?

This trial is for kidney transplant candidates who are highly sensitized to potential donors, meaning they have a low chance of finding a compatible donor. Participants must be on dialysis, listed for a transplant with high antibody levels against most donors, and free from serious infections like HIV or hepatitis C. They should not have severe heart issues or recent cancer history and must agree to use contraception.

What is being tested?

The study tests if carfilzomib (Kyprolis®) and belatacept (Nulojix®), along with bone marrow aspiration, can reduce immune sensitivity in patients awaiting kidney transplants. The goal is to increase their chances of finding a suitable donor more quickly.

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to the drugs' action on it, as well as general risks associated with medications such as infusion-related reactions and possible impact on organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I understand the study and can give my consent.

Select...

I am on the kidney transplant list with specific matching criteria.

Select...

I am on dialysis for end-stage kidney disease.

Select...

My latest TB test was negative or I've completed treatment for latent TB.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am taking medications that increase my health risks.

Select...

I have had an organ transplant.

Select...

I was recently hospitalized or treated for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (visit 0), weeks 16, 24, and 52 post treatment initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (visit 0), weeks 16, 24, and 52 post treatment initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (visit 0), weeks 16, 24, and 52 post treatment initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of subjects who do not meet a stopping rule for safety and remain free of all safety events listed in the outcome description, through Week 20 (Cohort 1) post treatment initiation or until receiving a transplant, whichever occurs earlier.

Proportion of subjects who do not meet a stopping rule for safety and remain free of all safety events listed in the outcome description, through Week 24 (Cohort 2) post treatment initiation or until receiving a transplant, whichever occurs earlier.

Proportion of subjects who meet any one of the pre-specified events detailed in the outcome description: from Baseline to Week 20 post treatment initiation - Cohort 1

+1 more

Secondary study objectives

Incidence of cytomegalovirus (CMV) disease within 20 weeks after starting treatment

Cytomegalovirus Infections

Incidence of cytomegalovirus (CMV) infection within 20 weeks after starting treatment (Cohort 1)

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2 (N=10 Subjects)Experimental Treatment3 Interventions

The enrollment of ten additional subjects and dosing regimen is dependent on the results in Cohort 1.° Per protocol, Carfilzomib administered intravenously: * Cycle 1 will consist of 2 doses in week 4 (Day 28 and 29). If tolerated, the dose will be increased and administered twice a week in weeks 5 (Day 35 and 36) and 6 (Day 42 and 43). * Cycle 2 will consist of a total of 6 doses, administered twice weekly in weeks 12 (Day 84 and 85), 13 (Day 91 and 92) and 14 (Day 98 and 99). Per protocol, Belatacept: -Belatacept will be administered intravenously on days 28 (week 4), 33 (week 5), and weeks 6, 8, 12, 16, then at a lower dose at week 20, 24, 28, 32, 36, 40, 44, 48, 52, and 56. Dosing is based on the recommended dose in the package insert. ° May be modified based on the safety and efficacy analysis of Cohort 1.

Group II: Cohort 1 (N=5 Subjects)Experimental Treatment3 Interventions

The two investigational agents used in this study are carfilzomib and belatacept. Per protocol, Carfilzomib administered intravenously: * Cycle 1 will consist of 2 doses in week 4 (Day 28 and 29). If tolerated, the dose will be increased and administered twice a week in weeks 5 (Day 35 and 36) and 6 (Day 42 and 43). * Cycle 2 will consist of a total of 6 doses, administered twice weekly in weeks 12 (Day 84 and 85), 13 (Day 91 and 92) and 14 (Day 98 and 99). Per protocol, Belatacept: -Belatacept will be administered intravenously on days 29 (week 4), 33 (week 5), and weeks 6, 8, 12, 16, then at a lower dose at week 20, 24, 28, 32, 36, 40, 44, 48, 52, and 56. Dosing is based on the recommended dose in the package insert.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

carfilzomib

2010

Completed Phase 2

~710

Bone marrow aspiration

2022

Completed Phase 2

~360