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

NCT05029310 | Completed Phase 4 DMC

• 1 other identifier: 148684
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperkalemia; Kidney Transplant

Keywords

kidney transplant; Hyperkalemia

Outcome Measures

Primary Outcomes (1)

• study potential interaction between patiromer and tacrolimus

  Log-transformed AUC0-tau of tacrolimus between patiromer vs. no patiromer

  two weeks

Secondary Outcomes (1)

• Determine effect of patiromer on potassium concentration.

  two weeks

Study Arms (1)

All patients use both patiromer and tacrolimus

EXPERIMENTAL

Pharmacokinetic investigation of tacrolimus performed in both the presence and absence of patiromer for all patients.

Drug: Patiromer Oral Product

Interventions

Patiromer Oral Product DRUG

interaction study

All patients use both patiromer and tacrolimus

Eligibility Criteria

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

You may qualify if:

• 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.
• Recipients 18 years of age or older.
• Hyperkalemia (K\>5 and \<6,0)
• Signed informed consent.

You may not qualify if:

• Concomitant treatment with: diltiazem, verapamil, fenytoin, carbamazapin, fluconazole, ketoconazole, vorikonazole, erythromycin, clarithromycin, resonium-calcium, and/or sodium zirconium cyclosilicate.
• Constipation, defined as fewer than three bowel movements per week.
• Hypomagnesemia less than 0.6 mmol/L.
• Serum potassium level of greater than 6.0 mEq/L.
• Increased immunologic risk patient (DSA, ABO-incompatible transplant).
• Hypersensitivity/allergy to patiromer.
• Other serious medical or psychiatric condition likely to interfere with participation.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0024, Norway

Location

MeSH Terms

Conditions

Hyperkalemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Geir Mjøen, MD

  MD

  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: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: Patients already taking tacrolimus start treatment with patiromer. After seven days tacrolimus kinetics are studied. Seven days after discontinuation of patiromer, tacrolimus kinetics are repeated.

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: August 31, 2021
• Study Start: September 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)