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Biological

Abatacept for Kidney Transplant Recipients

Phase 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 18 months post-randomization (24 months post-transplant)

Awards & highlights

Study Summary

This trial is studying 800 adult kidney transplant recipients to see if a biomarker can predict risk & if abatacept can improve outcomes.

Who is the study for?

This trial is for adult kidney transplant recipients who are on a stable medication regimen, have good kidney function (eGFRCKD-EPI 30-90 ml/min/1.73m^2) at 6 months post-transplant, and no acute rejection or significant infections. They must agree to use effective contraception and be able to consent. Exclusions include severe lung disease, certain viral infections like HIV or active hepatitis B, recent other vaccine or drug trials participation.Check my eligibility

What is being tested?

The study first observes 800 patients to see if their HLA-DR/DQ mismatch score can predict immune system risk after a transplant. Then it randomly assigns 300 eligible patients either to continue standard care or switch from Tacrolimus to Abatacept treatment, monitoring kidney function improvement and quality of life for 18 months.See study design

What are the potential side effects?

Abatacept may cause side effects such as infection risks due to immune system suppression, possible allergic reactions at the injection site since it's given subcutaneously (under the skin), and potentially increased risk of developing certain types of cancers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 18 months post-randomization (24 months post-transplant)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 18 months post-randomization (24 months post-transplant)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 18 months post-randomization (24 months post-transplant) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

In the Nested Randomized Control Trial (RCT) - Renal function, measured as the difference in eGFRCKD-EPI at 24-months between groups (adjusted for renal function at randomization).

Secondary outcome measures

In the Nested Randomized Control Trial (RCT) - Biopsy Proven Acute Rejection (BPAR) efficacy failure

In the Nested Randomized Control Trial (RCT) - Composite neurocognitive function (NIH-Toolbox Cognitive Battery) score

In the Observational Study - The occurrence of any alloimmune event

Side effects data

From 2023 Phase 3 trial • 613 Patients • NCT03086343

URINARY TRACT INFECTION

UPPER RESPIRATORY TRACT INFECTION

NASOPHARYNGITIS

HYPERTENSION

100%

80%

60%

40%

20%

Study treatment Arm

Abatacept

Upadacitinib 15 mg

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Nested RCT - Treatment Group (Abatacept)Experimental Treatment1 Intervention

Eligible subjects will be re-consented and randomized to the investigational (abatacept/Mycophenolate mofetil (MMF)/Pred) Arm. Starting with abatacept at a fixed dose (125 mg s.c. weekly) and eliminate Calcineurin Inhibitor (CNI) over ~3 months using serial Tacrolimus (TAC) C0 level targets to taper the dose. 2200 subjects will be followed for 18 months post-randomization, monitoring for safety and improvement in renal function, neurocognitive function, and a life participation patient reported outcome measure (PROM). Subjects who develop Biopsy Proven Acute Rejection (BPAR) will have concurrent serum/urine/tissue samples collected and stored.

Group II: Nested RCT - Control Group (SOC)Active Control1 Intervention

Eligible subjects will be re-consented and randomized to the control group (tacrolimus/Mycophenolate mofetil (MMF)/Pred) . 100 subjects will be and followed for 18 months post-randomization, monitoring for safety and improvement in renal function, neurocognitive function, and a life participation patient reported outcome measure (PROM). Subjects who develop Biopsy Proven Acute Rejection (BPAR) will have concurrent serum/urine/tissue samples collected and stored.

Group III: Observational Study - Full CohortActive Control1 Intervention

800 adults first kidney transplant recipients will be followed observationally to evaluate HLA-DR/DQ molecular mismatch (mMM) as a risk-stratifying prognostic biomarker. Donor-recipient HLA-DR/DQ mMM score will be determined at enrollment and recipients will be followed over 24-months post-kidney transplant for primary alloimmune events (i.e., TCMR, DSA, and ABMR). Standard of care (SOC) therapy will be used to satisfy the FDA requirement to prospectively evaluate the HLA-DR/DQ mMM score as a prognostic biomarker for post-kidney transplant outcomes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abatacept

2005

Completed Phase 4

~112150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,484,437 Total Patients Enrolled

Peter S Heeger, M.D.Study ChairCedars Sinai Medical Center: Transplantation

1 Previous Clinical Trials

178 Total Patients Enrolled

Peter Nickerson, M.D.Study ChairUniversity of Manitoba Max Rady College of Medicine - Transplantation

Media Library

Abatacept (Biological) Clinical Trial Eligibility Overview. Trial Name: NCT05917522 — Phase 2

Kidney Transplant Research Study Groups: Nested RCT - Treatment Group (Abatacept), Nested RCT - Control Group (SOC), Observational Study - Full Cohort

Kidney Transplant Clinical Trial 2023: Abatacept Highlights & Side Effects. Trial Name: NCT05917522 — Phase 2

Abatacept (Biological) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05917522 — Phase 2

Frequently Asked Questions

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

Who is eligible to participate in this research project?

"This medical trial is seeking 800 participants who have had kidney transplants and are between 18 to 70 years of age."

Answered by AI

Are researchers still accepting enrollees for this clinical experiment?

"According to the information found on clinicialtrials.gov, this medical trial is not actively recruiting patients at present; however, it was last edited June 20th 2023. Fortunately there are still 76 other trials that require participants right now."

Answered by AI

What potential perils are affiliated with Abatacept from Nested RCT?

"Since this is a Phase 2 clinical trial, meaning that there is limited evidence of safety but no data regarding efficacy, we at Power rate the safety of abatacept as a 2."

Answered by AI

Does this investigation accept volunteers above the age of 45?

"Adhering to the eligibility criteria, this trial has a lower age limit of 18 and an upper bound of 70."

Answered by AI

How many facilities are administering this experiment?

"This clinical trial is currently hosted by Cedars Sinai Medical Center: Transplantation in Los Angeles, California; Ronald Reagan UCLA Medical Center: Transplantation in New Haven, Connecticut; Yale University, School of Medicine: Transplantation in Weston, Florida as well as an additional 20 medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation

2023. "Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05917522.

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