Mycophenolate Mofetil for Kidney Transplant Recipients
(OPTIMA-KT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Most kidney transplant recipients take a combination of anti-rejection medicines for the rest of their life. One of these is called mycophenolate mofetil (MMF), also known by the brand name CellCept. While MMF helps protect the kidney, taking it for many years can cause infections, low blood counts, stomach problems, and a higher risk of certain cancers, problems that older adults are especially likely to experience.
We are doing this study to learn whether carefully and slowly stopping MMF in older adults who are doing well after their transplant is as safe as continuing MMF, when we use blood and urine tests to closely watch for any early signs of trouble. The information learned could help future kidney transplant patients use less medicine without losing their transplant.
Who Is on the Research Team?
Amber Paulus, PhD
Principal Investigator
Virginia Commonwealth University
Are You a Good Fit for This Trial?
This trial is for people over 60 who received a kidney transplant more than a year ago, are on stable anti-rejection medicine (tacrolimus), and have been doing well. Participants must be able to give consent and follow study instructions.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Mycophenolate Mofetil
- Prednisone
- Tacrolimus
Trial Overview
The study compares two groups: one continues taking the standard anti-rejection drugs including MMF, while the other gradually stops MMF under close monitoring using blood and urine tests to see if it's safe for low-risk older adults.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Mycophenolate Mofetil (MMF) is reduced to approximately 50% of baseline daily dose at Month 1, approximately 25% at Month 2, and discontinued at Month 3, remaining discontinued through Month 6 unless biomarker triggers prompt reinstatement. Tacrolimus trough is maintained at 5 to 8 ng/mL with monthly monitoring and coefficient of variation tracking; prednisone is continued at site-standard dose unless contraindicated.
Participants continue tacrolimus-based maintenance immunosuppression (tacrolimus, MMF, with or without prednisone)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Virginia Commonwealth University
Lead Sponsor
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