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

Sponsor
Oslo University Hospital
Study ID
NCT05029310
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 1, 2021
Status verified
Mar 2023
Primary completion
Feb 1, 2023
Completion
Feb 1, 2023

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All patients use both patiromer and tacrolimus
    Pharmacokinetic investigation of tacrolimus performed in both the presence and absence of patiromer for all patients.

Primary Outcome Measure

study potential interaction between patiromer and tacrolimus [ Time Frame: two weeks ]

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