Optimizing Immunosuppression in Low-Risk Older Adult Kidney Transplant Recipients (OPTIMA-KT): A Prospective, Randomized, Open-Label, Blinded-Endpoint Single-Site Pilot/Feasibility Trial of Biomarker-Guided Mycophenolate Mofetil Elimination

Summary

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.

Description

Eligibility

Age range

60+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Tacrolimus (Kidney transplant maintenance immunosuppression)

  Administration of Tacrolimus

• Drug
  Mycophenoate Mofetil

  Participants are administered MMF

• Drug
  Prednisone (SOC arm)

  Participants in SOC arm may be administered Prednisone as indicated

• Drug
  Prednisone (MMF Elimination arm)

  Participants in the MMF Elimination arm may be administered prednisone as indicated

Location