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

Part of paid clinical trials in New York, New York.

Sponsor
The Rogosin Institute
Study ID
NCT03229265
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Patiromer — DRUG
    Patiromer (8.4 grams) will be taken daily at 3 hours after oral tacrolimus and MMF dosing by subjects commencing 3 days (± 1 day) prior to visit 1.

Study Details

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.

Key Dates

Start date
Aug 1, 2017
Status verified
Apr 2020
Primary completion
Aug 7, 2019
Completion
Aug 7, 2019

Study Design

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

Arms

  • Experimental: Patiromer

Primary Outcome Measure

AUC [ Time Frame: Within 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Rogosin InstituteNew YorkNew York10021-

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The Rogosin Institute· New York, NY

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