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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (visit 0), weeks 16, 24, and 52 post treatment initiation
Awards & highlights

ADAPT Trial 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.Check my eligibility
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.See study design
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.

ADAPT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand the study and can give my consent.
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I am on the kidney transplant list with specific matching criteria.
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I am on dialysis for end-stage kidney disease.
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My latest TB test was negative or I've completed treatment for latent TB.

ADAPT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

ADAPT 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
2000
Completed Phase 2
~260
belatacept
2017
Completed Phase 4
~280

Find a Location

Who is running the clinical trial?

Rho Federal Systems Division, Inc.Industry Sponsor
40 Previous Clinical Trials
13,548 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,631 Previous Clinical Trials
4,126,653 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,266 Previous Clinical Trials
5,484,082 Total Patients Enrolled

Media Library

Belatacept (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT05017545 — Phase 1 & 2
Prospective Kidney Transplant Recipients Research Study Groups: Cohort 2 (N=10 Subjects), Cohort 1 (N=5 Subjects)
Prospective Kidney Transplant Recipients Clinical Trial 2023: Belatacept Highlights & Side Effects. Trial Name: NCT05017545 — Phase 1 & 2
Belatacept (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05017545 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are helping to test this new treatment?

"That is correct. The clinicaltrials.gov website suggests that the trial is still recruiting patients. According to the information available, the study was originally posted on December 28th 2021 and was last updated on January 11th 2022. They are 15 patients needed at 1 site."

Answered by AI

Are recruitment efforts for this experiment ongoing at the moment?

"The details published on clinicaltrials.gov show that this trial is ongoing and presently recruiting patients. The listing was first posted on December 28th, 2021 and last edited January 11th, 2022. They are looking for 15 individuals to participate at a single location."

Answered by AI

Will elderly patients be able to participate in this research?

"The age range for patients that this trial can enroll is from 18 to 65. However, if a patient falls outside of that age bracket, there are still 3 trials for those under 18 and 97 trials for seniors above the age of 65."

Answered by AI

Are there other examples of carfilzomib being used in a medical setting?

"At the moment, 98 different carfilzomib studies are underway. Of these, 15 are in Phase 3. The majority of research for this medication is taking place in Harrison, New york; although, there are 2692 total locations running clinical trials related to carfilzomib."

Answered by AI

Who would be able to gain the most from this research?

"This clinical trial is recruiting 15 participants with highly sensitized prospective kidney transplant recipients aged 18 and 65. Most importantly, candidates should meet the following criteria: Current cPRA >98 percent (with >5 years of waiting time) awaiting deceased donor transplant, Individuals who meet all of the following criteria are eligible for enrollment as study subjects-."

Answered by AI

What are the goals that we hope to achieve with this clinical trial?

"The primary outcome of this clinical trial is to assess the proportion of subjects who do not meet a stopping rule for safety and remain free of all of the safety events listed in the outcome description, through Week 20 post treatment initiation or until receiving a transplant, whichever occurs earlier. Secondary outcomes include Incidence of cytomegalovirus (CMV) infection within 20 weeks after starting treatment which is defined as CMV infection confirmed by the presence of detectable CMV in blood by polymerase chain reaction [PCR] diagnostic testing, regardless of whether signs or symptoms are present., Incidence of invasive fungal infections, mycobacterial"

Answered by AI

Is this research novel in any way?

"Carfilzomib has been under investigation since 2010 when Merck Sharp & Dohme LLC. ran the first 4420 person study. After this Phase 3 drug approval, there have been 98 active trials in 740 different cities and 40 nations."

Answered by AI

Which patients does carfilzomib help the most?

"Carfilzomib is often used to manage relapsed or refractory multiple myeloma. Additionally, carfilzomib has shown efficacy in treating steroid therapy, receptors, complement 3d, and therapeutic procedure patients."

Answered by AI
~8 spots leftby Feb 2027