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NCT03229265
Pharmacokinetic Study of Tacrolimus and Mycophenolate Mofetil in Kidney Transplant Recipients With Hyperkalemia Receiving Patiromer
Phase 4 trial testing Patiromer in Hyperkalemia in 8 participants. Completed in 7 August 2019.
7 August 2019
Quick facts
| Lead sponsor | The Rogosin Institute |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 1 August 2017 |
| Primary completion | 7 August 2019 |
| Estimated completion | 7 August 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Patiromer — full drug profile →
Conditions studied
- Hyperkalemia — all drugs for Hyperkalemia →
- Kidney Transplant — all drugs for Kidney Transplant →
Sponsor
The Rogosin Institute
Who can join
18 and older, any sex, with Hyperkalemia or Kidney Transplant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03229265
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Patiromer
Trials testing the same drug.
- NCT05766839 — Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age · Phase 2 · recruiting
- NCT04585542 — Comparison of Potassium Binders in the ER · Phase 4 · terminated
- NCT04142788 — RELieving Increasing oEdema Due to Heart Failure · Phase 4 · terminated
- NCT03888066 — Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure · Phase 3 · completed
- NCT03183778 — Use of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet. · Phase 4 · completed
Other recruiting trials for Hyperkalemia
Currently open trials in the same condition.
- NCT06366230 — Adding Urea to the Final Dialysis Fluid · Phase 1, PHASE2 · recruiting
- NCT06884267 — Hyperkalemia Quality Improvement Program (HK-QIP) Study · NA · recruiting
- NCT06940414 — Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in Community · recruiting
- NCT05766839 — Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age · Phase 2 · recruiting
- NCT06365684 — Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4 · Phase 4 · recruiting
Other The Rogosin Institute trials
Trials by the same sponsor.
- NCT05540457 — Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis) · NA · completed
- NCT04155216 — A Guided Meditation Program in Patients Undergoing Dialysis · NA · completed
- NCT04143100 — Anxiety and Symptom Burden in Hemodialysis Patients · completed
- NCT03698877 — Procalcitonin and Brain Natriuretic Peptides in Patients With Chronic Kidney Disease. · completed
- NCT03567837 — Fructose-induced Hepatic De Novo Lipogenesis in Adolescents With Obesity · NA · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03229265 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Rogosin Institute
- Last refreshed: 13 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03229265.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing