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New treatment option for Chronic Kidney Diseases
Official title Potassium Correction for RAAS Optimization in Chronic Kidney Disease
ClinicalTrials.gov ID: NCT06256991
What this study is testing
What is Patiromer 8400 MG [Veltassa]?
Patiromer 8400 MG [Veltassa] is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic kidney diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this placebo-controlled, double-blinded cross-over trial is to test whether patiromer, compared with placebo, better enables up-titration of RAAS-blocker treatment in patients with chronic kidney disease stage 3b/4. The main questions it aims to answer are: Does patiromer allow uptitration of irbesartan, resulting in a significant reduction in albuminuria and blood pressure?
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Groningen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Groningen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.