CompletedPhase 1

Subcutaneous Abatacept in Renal Transplant Recipients

United States16 participantsStarted 2023-08-02

Plain-language summary

After a kidney transplant, patients take drugs called anti-rejection drugs (immunosuppressives) to prevent their bodies from rejecting the new kidney. At present it is not possible to have a successful transplant without these drugs. These drugs make it possible for a person who receives the transplant to accept the "foreign" kidney. Most patients who get a transplant need to take anti-rejection medications for the rest of their lives, or for as long as the kidney continues to work. Researchers are looking to learn whether abatacept is as good as belatacept in preventing rejection, whether there are other benefits or harms associated with abatacept treatment, and possibly allows greater flexibility on patient's travel and time since abatacept is self-administered at home. This study is being done to answer these questions: Are weekly abatacept injections under the skin a safe and effective substitute for monthly belatacept intravenous (IV) infusions? and How well does the kidney function after switching from belatacept to abatacept?

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Must be able to understand and provide informed consent. * Male or Female, 18-70 years of age at the time of enrollment (all races and ethnicities) * Negative crossmatch (virtual or physical) at the time of transplant * No less than 8 weeks, no more than 20 weeks post-transplant at enrollment * A first-time renal transplant who has been treated with belatacept from the time of transplant, receiving tacrolimus (target trough 3-5 ng/ml), mycophenolate mofetil (or mycophenolic acid or azathioprine), prednisone (also see exclusion criteria). * eGFR ≥ 40ml/min/m2 \[using 2021 the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\]. * Prior documented evidence of Epstein-Barr virus (EBV) seropositivity must be available. * Female study participants of childbearing potential must have a negative pregnancy test before enrollment. * Agreement to use contraception that is more than 80% effective. * Vaccines are current as per the Division of Allergy, Immunology, and Transplantation (DAIT) guidance for patients in transplant trials. * Study participants must have a negative purified protein derivative (PPD) or negative testing for tuberculosis using an approved Interferon Gamma Release Assay (IGRA) blood test, such as QuantiFERON®-Gold tuberculosis (TB) or T-SPOT®-TB assay. PPD or IGRA testing must be documented to have been performed within the 52 weeks before enrollment. Patients with latent TB may become eligible after completion of treatment…

What they're measuring

Number of Participants Who Are Compliant With Self-administration

Timeframe: Up to 12 months post-transplantation, an average of 8 months

Number of Participants Who Remain Free of Biopsy-proven Acute T-cell Mediated Rejection (aTCMR) or Antibody-mediated Rejection (ABMR) as Defined by Banff Criteria at or Before 12 Months After Transplantation.

Timeframe: Up to 12 months post-transplantation, an average of 8 months

Number of Participants Presenting Serious Adverse Events

Timeframe: Up to 12 months post-transplantation, an average of 8 months

Number of Participants With Serious Infections

Timeframe: Up to 12 months post-transplantation, an average of 8 months

Number of Patients With Cytomegalovirus (CMV) Viremia Stratified by the Magnitude

Timeframe: Up to 12 months post-transplantation, an average of 8 months

Number of Patients With BK Viremia Stratified by the Magnitude

Timeframe: Up to 12 months post-transplantation, an average of 8 months

Number of Participants Who Develop Any Malignancy

Timeframe: Up to 12 months post-transplantation, an average of 8 months

Trial details

NCT IDNCT05975450

SponsorIdelberto Badell

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-14

Results submitted2026-02-03

View on ClinicalTrials.gov More Kidney Transplant Recipient trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants Who Are Compliant With Self-administration

Timeframe: Up to 12 months post-transplantation, an average of 8 months

Number of Participants Presenting Serious Adverse Events

Timeframe: Up to 12 months post-transplantation, an average of 8 months

Number of Participants With Serious Infections

Timeframe: Up to 12 months post-transplantation, an average of 8 months

Number of Patients With Cytomegalovirus (CMV) Viremia Stratified by the Magnitude

Timeframe: Up to 12 months post-transplantation, an average of 8 months

Number of Patients With BK Viremia Stratified by the Magnitude

Timeframe: Up to 12 months post-transplantation, an average of 8 months

Number of Participants Who Develop Any Malignancy

Timeframe: Up to 12 months post-transplantation, an average of 8 months