Actively Recruiting
Impact of Patiromer Treatment on Dietary Potassium Intake Restriction and Health-related Quality of Life and Nutrition in Patients on Chronic Dialysis Therapy: a Double-Blind, Prospective, Randomized, Placebo-Controlled Pilot Trial
Led by Mario Negri Institute for Pharmacological Research · Updated on 2025-09-04
40
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
This trial studies patients with end-stage kidney disease who are on chronic dialysis therapy and face the challenge of managing high potassium levels (hyperkalemia). It aims to evaluate whether the oral potassium binder patiromer can help reduce or remove the need for strict potassium dietary restrictions without increasing the risk of hyperkalemia. This phase III, randomized, double-blind, placebo-controlled study will explore how patiromer affects diet flexibility and health-related quality of life in these patients. Participants will be randomly assigned to receive either patiromer or a placebo daily for three months. The medication is taken every morning and is designed to lower potassium levels by binding potassium in the gut, exchanging it for calcium. The study controls for the number of dialysis sessions per week (two versus three) and carefully monitors how the treatment allows adjustments in potassium diet restrictions. Both groups will follow the same schedule, with medication separated by at least three hours from other oral drugs. Throughout the 12-week study, participants will have their serum potassium levels checked before each dialysis session. Researchers will monitor the safety and effectiveness of patiromer in maintaining potassium levels within a normal range while potentially improving diet and quality of life. The study includes careful tracking of side effects and overall health, aiming to find better treatment options for dialysis patients. Total participation lasts for three months of treatment with regular clinical assessments.
CONDITIONS
Brief Title
Patiromer and Diet/hrQoL in Chronic Dialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- More than 18 years old
- On chronic and stable dialysis therapy with three weekly sessions for at least three months due to end-stage kidney disease
- Pre-dialysis serum potassium between 4 and 5.5 mEq/L confirmed in two consecutive weeks without signs of hyperkalemia
- Stable therapy with RAS inhibitors or MRAs for at least three months and no potassium-sparing diuretics
- On a standardized and stable low-potassium diet
- Compliant with recommended diet
- Provided written informed consent
You will not qualify if you...
- Pre-dialysis hyperkalemia with potassium above 5.5 mEq/L
- Low magnesium levels (serum magnesium less than 1.7 mg/dL)
- High calcium levels (serum calcium above 10.5 mg/dL)
- Currently treated with potassium binding medications like Sodium polystyrene sulfonate or Sodium zirconium cyclosilate
- Currently treated with potassium-sparing diuretics
- Pre-dialysis potassium below 4.0 mEq/L
- Receiving only one or two dialysis sessions per week
- Poor compliance with potassium-restricted diet
- History of bowel obstruction, major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing difficulties
- Previous cardiac arrhythmias linked to low potassium
- Known allergy to patiromer or its ingredients
- Unable to understand study risks and benefits
- Presence of serious clinical conditions such as cancer (except non-metastatic skin cancers), active autoimmune diseases, treatment with steroids or immunosuppressants
- Severe or unstable heart failure requiring hospitalization or treatment changes
- Severe hypertension uncontrolled by multiple medications
- HIV positive
- Drug or alcohol abuse
- Pregnancy, breastfeeding, or planning pregnancy during the study or within 90 days after
- Planning to donate eggs or sperm during the same period
- Childbearing potential without highly effective contraception
- Involved in study planning or conduct
- Participated in another investigational study within the last month
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants are randomized to receive either patiromer or placebo daily for 3 months to manage serum potassium levels while on chronic dialysis.
Visits before every dialysis session during treatment
Trial Site Locations
Total: 1 location
1
Nephrology Unit, ASST Papa Giovanni XXIII
Bergamo, BG, Italy, 24127
Actively Recruiting
Research Team
P
Piero L Ruggenenti, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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