Immunosuppression Adjustment for Kidney Transplant Recipients

(CPAT-ISR Trial)

Recruiting at 15 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Must be taking: Tacrolimus, Mycophenolate, Corticosteroids

Must not be taking: Sirolimus, Everolimus, Belatacept, Azathioprine

Disqualifiers: Pregnancy, HIV, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

48 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will enroll individuals who have: * Completed primary series of mRNA COVID-19 vaccine, and * An antibody response ≤ 2500 U/mL measured at least 30 days after the last dose of vaccine. This group of patients is at high risk for severe COVID-19 disease due to pharmacologic immunosuppression and a high prevalence of non-transplant risk factors such as obesity and diabetes.

Research Team

Peter S. Heeger, MD

Principal Investigator

Translational Transplant Research Center, Icahn School of Medicine at Mount Sinai

Christian P. Larsen, MD, DPhil

Principal Investigator

Emory Transplant Center, Emory University School of Medicine

Dorry L. Segev, MD, PhD

Principal Investigator

Transplant Surgery, Johns Hopkins University School of Medicine

Eligibility Criteria

Adults over 18 who've had a kidney or liver transplant at least a year ago without recent rejection, on specific tacrolimus-based immunosuppression, with low antibody response after COVID-19 vaccination. Excludes those with other organ transplants, severe vaccine allergies, certain medical conditions or treatments that could affect the trial.

Inclusion Criteria

I don't have antibodies against donor tissues.

I had a kidney or liver transplant over a year ago and have had no rejection in the last 6 months.

Serum antibody negative or low at specified time points

Exclusion Criteria

I have received an organ transplant, but it was not a kidney or liver.

I am on an immunosuppressive regimen not listed in the trial details.

I am currently being treated for cancer, with some exceptions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a booster dose of mRNA COVID-19 vaccine with or without immunosuppression reduction

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person and virtual) at specified intervals

Treatment Details

Interventions

• Moderna Bivalent COVID-19 Vaccine
• Moderna COVID-19 Vaccine Booster
• Pfizer-BioNTech Bivalent COVID-19 Vaccine
• Pfizer-BioNTech COVID-19 Vaccine Booster
• SOC IS Reduction
• SOC IS Regimen

Trial Overview The study tests if reducing immunosuppression and administering updated Pfizer-BioNTech or Moderna COVID-19 vaccines can better protect transplant recipients against COVID-19 while maintaining organ function.

Participant Groups

Group I: Pfizer-BioNTech COVID-19 Vaccine 2023-2024 + SOC IS Regimen Experimental Treatment 2 Interventions

Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. SOC IS: Standard of Care transplant immunosuppression regimen

Group II: Pfizer-BioNTech COVID-19 Vaccine 2023-2024 + SOC IS Reduction Experimental Treatment 2 Interventions

Participants will receive an additional dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024, with concurrent reduction of their standard of care transplant immunosuppression regimen (IS), per protocol. SOC IS Reduction: Standard of Care transplant immunosuppression regimen reduction, per protocol

Group III: Moderna COVID-19 Vaccine 2023-2024 + SOC IS Regimen Experimental Treatment 2 Interventions

Participants will receive an additional dose (1 dose) of the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. SOC IS: Standard of Care transplant immunosuppression regimen

Group IV: Moderna COVID-19 Vaccine 2023-2024 + SOC IS Reduction Experimental Treatment 2 Interventions

Participants will receive a study dose (1 dose) of the Moderna COVID-19 Vaccine 2023-2024, with concurrent reduction of their standard of care transplant immunosuppression regimen (IS), per protocol. SOC IS Reduction: Standard of Care transplant immunosuppression regimen reduction, per protocol

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

PPD DEVELOPMENT, LP

Industry Sponsor

Trials

167

Recruited

38,000+

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

PPD Development, LP

Industry Sponsor

PPD

Industry Sponsor

Trials

162

Recruited

36,600+

Dr. Austin Smith

PPD

Chief Medical Officer since 2020

Doctor of Medicine from the Royal College of Surgeons in Ireland

David Simmons

PPD

Chief Executive Officer since 2012

Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+