Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03229265
Other study ID # 1606017355
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 1, 2017
Est. completion date August 7, 2019

Study information

Verified date April 2020
Source The Rogosin Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 inclusion and exclusion criteria during the screening visit. There will be 2 study visits (visit 0 and visit 1) for each subject after successful screening. Visit 0 occurs within 14 days (± 3 days) after screening. Visit 1 occurs at 7 days (± 3 days) after visit 0. There will be 3 clinical visits (standard of care) after visit 1. A total of 6 visits are anticipated for this study.

Standard diet for lunch and dinner will be provided to subjects during visit 0 and visit 1. Meals provided will be monitored in relationship to C0 and C12.

During screening visit, blood tests for baseline BMP, aldosterone, magnesium, tacrolimus, DSA, and MMF will be obtained. If applicable, concomitant fludrocortiosone will be stopped prior to screening.

During visit 0, tacrolimus levels will be drawn immediately before (0 hr) and at 8 intervals after dosing (1,2,3,4,5,6,9,12 hrs). MMF levels will be drawn immediately before (0 hr) and at 9 intervals after dosing (1,2,3,4,5,6,7,9,12 hrs). Basic metabolic profile and serum magnesium levels will be drawn immediately before tacrolimus dosing. Oral MMF and tacrolimus will be dosed at 8am ± 1hr.

Enrollment is defined as the first day when subject receives patiromer treatment. 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. No tacrolimus or MMF dosing changes are allowed between visit 0 and 1. The addition of new concomitant drugs causing interactions with tacrolimus and MMF are prohibited between visit 0 and 1.

During visit 1, subjects will follow the same protocol of blood draws as visit 0. Tacrolimus levels will be drawn immediately before (0 hr) and at 8 intervals after tacrolimus dosing (1,2,3,4,5,6,9,12 hrs). MMF levels will be drawn immediately before (0 hr) and at 9 intervals after MMF dosing (1,2,3,4,5,6,7,9,12 hrs). Basic metabolic profile and serum magnesium levels will be drawn immediately before tacrolimus dosing. Patiromer at 8.4 grams will be given 3 hrs after tacrolimus and MMF dosing. Oral MMF and tacrolimus will be dosed at 8am ± 1hr.

All subjects will followup for clinical visits (2-4) with the PI or their transplant nephrologists after visit 1 according to schedule (see appendix for study visit events). Subjects will complete study by 30 days (± 7 days) after visit 0. Adjustment of patiromer dosing is at the discretion of PIs after visit 2. After completion of study visits, subjects will continue to follow with transplant clinic monthly for 2 months or sooner if clinically indicated per the discretion of the treating transplant nephrologist. After 2 months, clinic visits will be conducted per routine clinic schedule.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date August 7, 2019
Est. primary completion date August 7, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Male or female, 18 years of age or older.

2. 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.

3. Kidney transplant recipient.

4. Must be receiving MMF for maintenance immunosuppression

5. Must be receiving tacrolimus for maintenance immunosuppression

6. Subjects must have hyperkalemia (serum potassium = 5.0 mEq/L and = 6.0 mEq/L).

7. Prior to enrollment, subjects must be taking a steady dose of tacrolimus for 3 days.

Exclusion Criteria:

1. Use of Kayexalate 1 day prior to screening visit.

2. Serum potassium level of greater than 6.0 mEq/L at screening.

3. Serum magnesium level of less than 1.0mg/dL at screening.

4. Acute rejection episode within 30 days prior to enrollment.

5. Anemia with hemoglobin level of = 9.0 g/dL prior to screening.

6. Patient has hypersensitivity to patiromer.

7. Receiving maintenance corticosteroid for immunosuppression

8. Serious medical (including history of cardiac arrhythmias) or psychiatric illness likely to interfere with participation in this clinical study.

9. Patients with known donor-specific antibodies.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Patiromer
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.

Locations

Country Name City State
United States The Rogosin Institute New York New York

Sponsors (2)

Lead Sponsor Collaborator
The Rogosin Institute Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Serum potassium levels To assess the effect of patiromer in reducing hyperkalemia. Investigators will measure the serum potassium levels after the administration of the study drug patiromer. Within 30 days
See also
  Status Clinical Trial Phase
Completed NCT04087720 - Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant Phase 4
Completed NCT03749356 - Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients Phase 4
Withdrawn NCT05811468 - Study Correlation Between Blood, Tissue Gene Expression, Donor Derived Cell Free DNA and Histopathology in Kidney Transplant Recipients
Completed NCT03527238 - Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine Phase 2
Completed NCT00498576 - Melatonin and Adiponectin in Hypertensive Kidney Transplant N/A
Completed NCT00642655 - Rituximab and Intravenous Immunoglobulin (IVIG) for Desensitization in Renal Transplantation Phase 1/Phase 2
Completed NCT00374400 - The Paired Donation Consortium Paired Donation Program N/A
Completed NCT01710033 - A Study Of CP-690,550 In Stable Kidney Transplant Patients Phase 1
Completed NCT00205257 - Prediction of Acute Rejection in Renal Transplant Phase 1
Completed NCT02711826 - Treg Therapy in Subclinical Inflammation in Kidney Transplantation Phase 1/Phase 2
Withdrawn NCT03978494 - Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients. Phase 1
Completed NCT03837522 - Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies N/A
Not yet recruiting NCT06025240 - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Completed NCT05029310 - Effects of Patiromer on Pharmacokinetics of Immunosuppresive Drugs in Renal Transplant Recipients Phase 4
Completed NCT03644485 - Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac (or Circulatory) Death (DCD) Kidney Transplant Recipients Phase 4
Active, not recruiting NCT02409901 - Effects of Personalized Physical Rehabilitation in Kidney Transplant Recipients N/A
Completed NCT01047410 - ACtive Care After Transplantation, the ACT Study N/A
Completed NCT00940940 - Safety and Immunogenicity of Zostavax Vaccine in Patients Undergoing Living Donor Kidney Transplantation Phase 4
Completed NCT00217126 - The Study of Long-term Deterioration of Kidney Transplants. Phase 4
Completed NCT00270712 - A Study of Factors That Affect Long-Term Kidney Transplant Function