Using patiromer to improve blood pressure treatment in chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.