Effects of Patiromer on Pharmacokinetics of Immunosuppresive Drugs in Renal Transplant Recipients

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Patiromer lowers potassium effectively in patients with hyperkalemia and chronic kidney disease. Patients with a kidney transplant usually have reduced renal function and may also develop hyperkalemia. However, potential interactions between immunosuppressive medications and patiromer have not been evaluated. These interactions could involve change in AUC of immunosuppressive drugs, such as calcineurin inhibitors or mycophenolate, or increased risk of hypomagnesemia, since both tacrolimus and patiromer have this potential side effect. We wish to evaluate potential interactions to ensure safe use of this drug in the transplant population.

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

Details

• Lead Sponsor: Oslo University Hospital

Criteria

Inclusion Criteria:

1. Renal transplant recipients, at least 3 weeks after transplantation, who receive Tacrolimus as part of their immunosuppressive therapy, with stabile tacrolimus dose and trough tacrolimus concentration.

2. Recipients 18 years of age or older.

3. Hyperkalemia (K>5 and <6,0)

4. Signed informed consent.

Exclusion Criteria:

1. Concomitant treatment with: diltiazem, verapamil, fenytoin, carbamazapin, fluconazole, ketoconazole, vorikonazole, erythromycin, clarithromycin, resonium-calcium, and/or sodium zirconium cyclosilicate.

2. Constipation, defined as fewer than three bowel movements per week.

3. Hypomagnesemia less than 0.6 mmol/L.

4. Serum potassium level of greater than 6.0 mEq/L.

5. Increased immunologic risk patient (DSA, ABO-incompatible transplant).

6. Pregnancy or suspected pregnancy (pregnancy is excluded at time of transplantation by measuring HCG, kidney transplanted patients should not become pregnant before at least one year after transplant, and no transplanted patient has ever become pregnant during the first weeks after transplantation. They are all informed regarding different types of contraception). Fertile women will be tested for pregnancy before inclusion.

7. Hypersensitivity/allergy to patiromer.

8. Other serious medical or psychiatric condition likely to interfere with participation.