Status:
COMPLETED
Pharmacokinetic Study of Tacrolimus and Mycophenolate Mofetil in Kidney Transplant Recipients With Hyperkalemia Receiving Patiromer
Lead Sponsor:
The Rogosin Institute
Collaborating Sponsors:
Weill Medical College of Cornell University
Conditions:
Hyperkalemia
Kidney Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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, cur...
Detailed Description
This is an open-label single center pharmacokinetic study of kidney transplant recipients with hyperkalemia receiving tacrolimus and MMF-based immunosuppression. Subjects will be screened for inclusi...
Eligibility Criteria
Inclusion
- Male or female, 18 years of age or older.
- 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.
- Kidney transplant recipient.
- Must be receiving MMF for maintenance immunosuppression
- Must be receiving tacrolimus for maintenance immunosuppression
- Subjects must have hyperkalemia (serum potassium ≥ 5.0 mEq/L and ≤ 6.0 mEq/L).
- Prior to enrollment, subjects must be taking a steady dose of tacrolimus for 3 days.
Exclusion
- Use of Kayexalate 1 day prior to screening visit.
- Serum potassium level of greater than 6.0 mEq/L at screening.
- Serum magnesium level of less than 1.0mg/dL at screening.
- Acute rejection episode within 30 days prior to enrollment.
- Anemia with hemoglobin level of ≤ 9.0 g/dL prior to screening.
- Patient has hypersensitivity to patiromer.
- Receiving maintenance corticosteroid for immunosuppression
- Serious medical (including history of cardiac arrhythmias) or psychiatric illness likely to interfere with participation in this clinical study.
- Patients with known donor-specific antibodies.
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03229265
Start Date
August 1 2017
End Date
August 7 2019
Last Update
April 13 2020
Active Locations (1)
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1
The Rogosin Institute
New York, New York, United States, 10021