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Vaccine
Immunosuppression Adjustment for Kidney Transplant Recipients (CPAT-ISR Trial)
Phase 2
Waitlist Available
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
Negative for anti-donor human leukocyte antigens (HLA) antibodies at screening
Currently taking a tacrolimus-based immunosuppressive regimen as specified
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 0, prior to study vaccination), month 1, 3, 6, 9 and 12
Awards & highlights
CPAT-ISR Trial Summary
This trial is for people who have completed a 2-4 dose course of either the Moderna or Pfizer mRNA-based COVID-19 vaccine, and have an antibody response of ≤ 250 U/mL. This group is at high risk for severe COVID-19 disease.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include typical vaccine reactions like sore arm, fever, fatigue; risk of organ rejection due to reduced immunosuppression; and possible interaction with existing medications.
CPAT-ISR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I don't have antibodies against donor tissues.
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I am currently on a tacrolimus-based medication plan for my immune system.
Select...
I have received at least 3 doses of Moderna or Pfizer COVID-19 vaccine.
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I understand the study and can give my consent.
CPAT-ISR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 0, prior to study vaccination), month 1, 3, 6, 9 and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 0, prior to study vaccination), month 1, 3, 6, 9 and 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The primary endpoint is the -fold increase in antibody titer (using the Roche Elecsys® anti-SARS-CoV-2 S assay) from before receiving the study dose of vaccine to 30 days after the study dose of vaccine.
Secondary outcome measures
Change from Baseline in Anti-SARS-CoV-2 Antibody Levels at Day 30
Change from Baseline in SARS-CoV-2 Antibody Levels
Fold Increase in SARS-CoV-2 Antibody Levels: Limited to Participants With Detectable Antibody Levels at Baseline (Day 0)
+13 moreCPAT-ISR Trial Design
4Treatment groups
Experimental Treatment
Group I: Pfizer-BioNTech COVID-19 Vaccine 2023-2024 + SOC IS RegimenExperimental Treatment2 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 ReductionExperimental Treatment2 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 RegimenExperimental Treatment2 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 ReductionExperimental Treatment2 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
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,316 Total Patients Enrolled
PPDIndustry Sponsor
159 Previous Clinical Trials
36,515 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,255 Previous Clinical Trials
14,819,521 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received an organ transplant, but it was not a kidney or liver.My screening test for anti-donor antibodies was negative.I am on an immunosuppressive regimen not listed in the trial details.I am currently being treated for cancer, with some exceptions.I received a kidney or liver transplant over a year ago and have had no rejection in the last 6 months.I don't have antibodies against donor tissues.I am not on any immune-suppressing drugs except for those needed after a transplant.I had a kidney or liver transplant over a year ago and have had no rejection in the last 6 months.I am taking Tacrolimus with MMF or MPA, possibly with a steroid.I have an autoimmune disease that could worsen if I reduce my immunosuppression treatment.I am HIV positive.I am currently on a tacrolimus-based medication plan for my immune system.I have received at least 3 doses of Moderna or Pfizer COVID-19 vaccine.I am 18 years old or older.I completed my primary COVID-19 vaccination or latest booster at least 60 days ago.My medication for organ transplant was changed due to rejection.I haven't taken COVID-19 treatment or prevention drugs in the last 6 months.I do not have any untreated active infections.I understand the study and can give my consent.I have not taken cell-depleting drugs in the last year.I have received specific COVID-19 vaccines.My graft is not functioning well.I am 18 years old or older.I understand the study details and can give my consent.
Research Study Groups:
This trial has the following groups:- Group 1: Pfizer-BioNTech COVID-19 Vaccine 2023-2024 + SOC IS Reduction
- Group 2: Pfizer-BioNTech COVID-19 Vaccine 2023-2024 + SOC IS Regimen
- Group 3: Moderna COVID-19 Vaccine 2023-2024 + SOC IS Regimen
- Group 4: Moderna COVID-19 Vaccine 2023-2024 + SOC IS Reduction
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this particular drug combination been tested before in other research studies?
"There are currently 265 clinical trials studying SOC IS Regimen, with 45 of them in Phase 3. While Miami, Florida has a high concentration of research institutions running these tests, there are 2,681 different locations around the world where patients can participate."
Answered by AI
Could you explain what potential risks are associated with the SOC IS Regimen?
"This SOC IS Regimen only has evidence to support its safety, as opposed to efficacy, so it was given a score of 2."
Answered by AI
Are there any sites running this study in North America?
"Weill Cornell Medicine in New york, New York, University of California San Francisco Health in San Francisco, California and University of Pittsburgh in Pittsburgh, Pennsylvania are all running this clinical trial. Additionally, there are 15 other locations where this trial is taking place."
Answered by AI
Are investigators still enrolling participants for this research?
"The clinical trial is still active and recruiting patients, as stated on clinicaltrials.gov. The listing was created on December 6th, 2021 and was last updated October 31st, 2022. There are 400 total spots open for patients at 15 different sites."
Answered by AI
What is the standard SOC IS Regimen used to treat patients with?
"SOC IS Regimen is most typically used to treat atopic dermatitis. However, it can also be given to patients suffering from conditions like liver or kidney transplant rejection and psoriasis."
Answered by AI
Who else is applying?
What state do they live in?
Texas
California
What site did they apply to?
University of California, San Diego
Houston Methodist
What portion of applicants met pre-screening criteria?
Did not meet criteria
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