Pharmacokinetic Study of Tacrolimus and Mycophenolate Mofetil in Kidney Transplant Recipients With Hyperkalemia Receiving Patiromer

• Status: Completed
• Trial end date: 2019-08-07
• Target enrollment: 0
• Participant gender: All

Summary

Hyperkalemia (high potassium in blood) is a common condition found in kidney transplant patients. Risk factors include poor kidney function and exposure to various drugs. Regardless of the causes, current treatment options are limited. Previously, the only available potassium binder for lowering potassium in the blood is sodium polystyrene sulfonate, which has unknown drug interaction profile with transplant medications. Patiromer is a newly approved potassium binder indicated for the treatment of hyperkalemia. Kidney transplant patients with hyperkalemia may benefit from patiromer. However, the interaction of patiromer and transplant medications has not been studied. The goal of this study is to look into the drug interactions between patiromer and transplant medications.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Rogosin Institute
• Collaborator: Weill Medical College of Cornell University
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

1. Male or female, 18 years of age or older.

2. Patient is capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study.

3. Kidney transplant recipient.

4. Must be receiving MMF for maintenance immunosuppression

5. Must be receiving tacrolimus for maintenance immunosuppression

6. Subjects must have hyperkalemia (serum potassium ≥ 5.0 mEq/L and ≤ 6.0 mEq/L).

7. Prior to enrollment, subjects must be taking a steady dose of tacrolimus for 3 days.

Exclusion Criteria:

1. Use of Kayexalate 1 day prior to screening visit.

2. Serum potassium level of greater than 6.0 mEq/L at screening.

3. Serum magnesium level of less than 1.0mg/dL at screening.

4. Acute rejection episode within 30 days prior to enrollment.

5. Anemia with hemoglobin level of ≤ 9.0 g/dL prior to screening.

6. Patient has hypersensitivity to patiromer.

7. Receiving maintenance corticosteroid for immunosuppression

8. Serious medical (including history of cardiac arrhythmias) or psychiatric illness likely to interfere with participation in this clinical study.

9. Patients with known donor-specific antibodies.