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Immunosuppressant

Daratumumab + Belatacept for Kidney Transplant Candidates (ATTAIN 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
United Network for Organ Sharing (UNOS) listed listed with current calculated panel reactive antibodies (cPRA) ≥99.9% or >98% (with >5 years of waiting time) awaiting deceased donor transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (visit 0) up to 52 weeks post treatment initiation
Awards & highlights

ATTAIN Trial Summary

This trial is testing whether two drugs can help people who need kidney transplants but have a hard time finding a compatible donor.

Who is the study for?
This trial is for kidney transplant candidates who are highly sensitized (cPRA ≥99.9% or >98% with long wait times) and on hemodialysis, able to consent, HIV and Hepatitis C negative, immune to certain viruses like EBV and TB, not pregnant or nursing, willing to use contraception. Excluded are those with serious diseases besides kidney failure, past transplants or immunodeficiencies, recent infections requiring hospitalization or antibiotics.Check my eligibility
What is being tested?
The study tests if daratumumab (Darzalex®) and belatacept (Nulojix®), along with a bone marrow aspiration procedure can reduce the immune system's sensitivity in prospective kidney transplant recipients making it easier for them to find compatible donors.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site where drugs are given into the vein; increased risk of infections due to immune suppression; possible blood disorders; allergic reactions; fatigue; and other organ-specific inflammation.

ATTAIN 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 UNOS list for a transplant with a high antibody level or long wait time.
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I am on dialysis for end-stage kidney disease.
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I have been tested for TB using PPD or a blood test.
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I have completed treatment for latent TB infection.
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My latest TB test was negative or I've completed treatment for latent TB.
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I am of childbearing age and have a negative pregnancy test.
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I am vaccinated or immune to specific diseases including varicella and measles.

ATTAIN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (visit 0) up to 52 weeks post treatment initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (visit 0) up to 52 weeks 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
Transplantation
Proportion of subjects who meet any one of the pre-specified events detailed in the outcome description: from Baseline up to Week 26 - Cohort 1
Proportion of subjects who meet any one of the pre-specified events detailed in the outcome description: from Baseline up to Week 26 - Cohort 2
Secondary outcome measures
Incidence of cytomegalovirus (CMV) disease within 16 weeks after starting treatment
Incidence of cytomegalovirus (CMV) disease within 26 weeks after starting treatment
Incidence of cytomegalovirus (CMV) disease within 52 weeks after starting treatment
+8 more

ATTAIN Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2 (N=10 Subjects)Experimental Treatment3 Interventions
The enrollment of ten additional subjects is dependent on the results in Cohort 1. Multiple intravenous infusions of daratumumab and belatacept over 14 weeks:° Daratumumab will be administered intravenously at a dose of 8 mg/kg for the first dose, then 16 mg/kg for subsequent given weekly for 3 weeks, then every 2 weeks for 2 doses (week 9 and week 11). The dose administered will be calculated based on the actual body weight of the subject at each visit. Belatacept will be administered intravenously at a dose of 10 mg/kg every 2 weeks starting at week 8 (dosed at weeks 8, 10, 12, 14, 16 and 18). The total infusion dose of belatacept will be based on the actual body weight of the subject at the baseline visit and will not be modified during the course of therapy, unless there is a change in body weight of greater than 10%. Was modified based on the safety and efficacy analysis of Cohort 1.
Group II: Cohort 1 (N=5 Subjects)Experimental Treatment3 Interventions
Multiple intravenous infusions of daratumumab and belatacept over 10 weeks: Daratumumab will be administered intravenously at a dose of 8 mg/kg weekly for 4 weeks, then every other week for 4 weeks (week 9 and week 11). The dose administered will be calculated based on the actual body weight of the subject at each visit. Belatacept will be administered intravenously at a dose of 10 mg/kg every 2 weeks starting at week 8 (dosed at weeks 8, 10, 12, and 14). The total infusion dose of belatacept will be based on the actual body weight of the subject at the baseline visit, and will not be modified during the course of therapy, unless there is a change in body weight of greater than 10%.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
daratumumab
2017
Completed Phase 2
~60
Bone marrow aspiration
2000
Completed Phase 2
~260
belatacept
2017
Completed Phase 4
~280

Find a Location

Who is running the clinical trial?

Immune Tolerance Network (ITN)NETWORK
67 Previous Clinical Trials
7,915 Total Patients Enrolled
Rho Federal Systems Division, Inc.Industry Sponsor
41 Previous Clinical Trials
13,606 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,485,222 Total Patients Enrolled

Media Library

Belatacept (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT04827979 — 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: NCT04827979 — Phase 1 & 2
Belatacept (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04827979 — Phase 1 & 2

Frequently Asked Questions

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

What is the scope of participants enrolled in this research trial?

"Affirmative. Data on clinicaltrials.gov indicates that this medical research, which was first published on November 1st 2021, is actively looking for participants. Approximatively 15 subjects need to be acquired from a single healthcare institution."

Answered by AI

Is the age restriction for this investigation limited to adults only?

"This clinical trial stipulates that applicants must be aged between 18 and 65. There are an additional 3 studies dedicated to minors, whilst 149 trials cater specifically to those above the age of 65."

Answered by AI

Is this medical research still open to volunteers?

"The records on clinicaltrials.gov demonstrate that this medical investigation has been actively recruiting since November 1st 2021 and was last edited January 27th 2022."

Answered by AI

What are the principal applications of daratumumab?

"Daratumumab is a common therapeutic intervention for amyloidosis and other ailments, including refractory multiple myeloma, transplant rejection, kidney issues, and biological response modifiers."

Answered by AI

What therapeutic goals is this medical trial attempting to achieve?

"The primary focus of this experiment is to measure the proportion of patients who remain free from safety events up to 26 weeks post initiation. Secondary objectives include ascertaining the frequency and risk factors associated with cytomegalovirus infection, biopsy-proven acute or chronic antibody mediated rejection (AMR) within 52 weeks after transplantation for those undergoing a kidney transplant, as well as determining the incidence rate of CMV disease within one year following treatment commencement."

Answered by AI

Am I eligible to take part in this investigation?

"This research project is seeking 15 individuals aged 18-65 who have been identified as prospective kidney transplant recipients with high sensitization. Eligible participants must satisfy the following conditions: cPRA >98% with human leukocyte antigen (HLA)-incompatible approved living donor who have not received a transplant after 1 year in a paired kidney exchange program are also eligible, Individuals who meet all of the above criteria may enrol as study subjects."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Daratumumab and Belatacept for Desensitization
2021. "Daratumumab and Belatacept for Desensitization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04827979.
~8 spots leftby Mar 2027
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