Using patiromer to improve blood pressure treatment in chronic kidney disease
Potassium Correction for Renin-angiotensin-aldosterone System Optimization in Chronic Kidney Disease
PHASE4 · University Medical Center Groningen · NCT06256991
This study is testing if a medication called patiromer can help improve blood pressure treatment for people with chronic kidney disease by making another medication work better.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen (other) |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06256991 on ClinicalTrials.gov |
What this trial studies
This is a placebo-controlled, double-blinded cross-over trial designed to evaluate the effectiveness of patiromer in facilitating the up-titration of irbesartan in patients with chronic kidney disease stages 3b and 4. Participants will undergo a run-in period before being randomized to receive either patiromer or a placebo during two 12-week study periods, separated by a washout phase. The primary outcomes include the reduction of albuminuria and blood pressure, with safety monitored through plasma potassium levels. The trial aims to determine if patiromer can enhance the efficacy of RAAS-blocker treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with chronic kidney disease stage 3b or 4 and elevated blood pressure.
Not a fit: Patients with a history of severe hyperkalemia or those on certain medications that may interfere with the study will not benefit.
Why it matters
Potential benefit: If successful, this study could lead to improved management of blood pressure and kidney function in patients with chronic kidney disease.
How similar studies have performed: Other studies have shown promise in using patiromer for potassium management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years; * CKD stage 3b-4 (eGFR 15-44 mL/min/1.73 m2) * Albumin-creatinine ratio \>3 mg/mmol, or proteinuria \>0.05g/24u, or protein-creatinine ratio \> 5mg/mmol * Systolic blood pressure \>130 mmHg or use of one or more antihypertensive drugs; * Serum K+ 4.0-5.0 mmol/L; * On sub-maximal dose ACEi/ARB Exclusion Criteria: * prior ACEi/ARB dose reduction due to a drop in eGFR by \>25% in the last year; * history of severe hyperkalaemia (\>6.0 mmol/L) in the last year; * pregnancy or breastfeeding * life expectancy \<12 months * the use of lithium, potassium-sparing diuretics, potassium supplements, trimethoprim or NSAIDS * kidney transplant recipients, or diagnosis of autosomal dominant polycystic kidney disease or other non-glomerular kidney disease
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Liffert Vogt, prof. dr. — Amsterdam University Medical Centre
- Study coordinator: Martin de Borst, prof. dr.
- Email: m.h.de.borst@umcg.nl
- Phone: +31503616161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Kidney Diseases, Hyperkalemia, Hypertension