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

NCT03229265 | Completed Phase 4 FDA Drug

• 1 other identifier: 1606017355
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Hyperkalemia; Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• AUC

  Investigate the pharmacokinetics of tacrolimus and mycophenolate mofetil in kidney transplant recipients receiving patiromer. Investigators will obtain serum levels of tacrolimus and mycophenolate mofetil before and after the administration of the study drug patiromer. Investigators will measure the areas under the curve of tacrolimus and mycophenolate mofetil before and after exposure to patiromer.

  Within 30 days

Secondary Outcomes (1)

• Serum potassium levels

  Within 30 days

Study Arms (1)

Patiromer

EXPERIMENTAL

Drug: Patiromer

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.

Patiromer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Rogosin Institute: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

The Rogosin Institute

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Hyperkalemia

Interventions

patiromer

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jun Lee, MD

  The Rogosin Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: July 25, 2017
• Study Start: August 1, 2017
• Primary Completion: August 7, 2019
• Study Completion: August 7, 2019
• Last Updated: April 13, 2020

Record last verified: 2020-04

Locations

US (1)