Protocol Title:  Pharmacokinetic Study of Tacrolimus and Mycophenolate Mofetil in Kidney Transplant Recipients with Hyperkalemia Receiving Patiromer

Principal Investigator:  Jun Lee, M.D.
Office Number: (212) 746-1570 / E-mail: jblee@nyp.org

Study Status:  Open for Enrollment

Brief Summary of Protocol:  High potassium in blood (hyperkalemia) is a common condition found in kidney transplant patients.  Risk factors include poor kidney function and exposure to various drugs and current treatment options are limited.

The Food and Drug Administration (FDA) approved patiromer, the study drug, for lowering high blood potassium levels.  Kidney transplant patients with hyperkalemia may benefit from patiromer, but the interaction with transplant medications has not been studied.  The purpose of this study is to test if patiromer will interfere with the transplant medications tacrolimus and mycophenolate mofetil (MMF).

Potential candidates are male or female kidney transplant recipients, 18 years or older, with high blood potassium levels and are taking tacrolimus and MMF for maintenance immunosuppression.  Additional eligibility criteria will be discussed upon contacting the study team.   

Participation in this study will last approximately two months and will include six visits to our center.  After screening, eligible participants will be provided with the study drug, which will be taken daily for 30 days and asked to return in two weeks.  The next two visits will take place one week apart and participants will need to stay at our center for repeat blood draws over a 12-hour period.  Participants will then return once a week for three standard of care clinical visits.  

Potential Benefits:  There is no guarantee that subjects will benefit personally from this study. However, participation in this study may benefit others in the future.

IRB Information:  Weill Cornell Medical College
Protocol # 1606017355 

Sponsor:  The Rogosin Institute                                                             
ClinicalTrials.gov Identifier:  NCT1606017355  

Funding:  Relypsa, Inc. is providing a research grant and study drug (Patiromer) for this study, and is not involved in, or collaborating on, the study design or conduct.