Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06858280

Patiromer and Diet/hrQoL in Chronic Dialysis

Led by Mario Negri Institute for Pharmacological Research · Updated on 2025-09-04

40

Participants Needed

1

Research Sites

51 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a phase III, prospective, randomized, double-blind, placebo-controlled, single-center, pilot trial, aimed at assessing whether treatment with the oral potassium binder patiromer as compared to placebo allows withdrawal or down-titration of potassium dietary restriction without increasing the risk of hyperkalemia in chronic dialysis patients.

CONDITIONS

Official Title

Patiromer and Diet/hrQoL in Chronic Dialysis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • More than 18 years old
  • Receiving 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 symptoms of hyperkalemia
  • Stable treatment for at least 3 months with RAS inhibitors or MRAs, no potassium-sparing diuretics
  • Following a standardized and stable low-potassium diet
  • Compliance with the recommended diet
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Pre-dialysis hyperkalemia with potassium above 5.5 mEq/L during the long interdialytic period
  • Serum magnesium below 1.7 mg/dL (hypomagnesemia)
  • Serum calcium above 10.5 mg/dL (hypercalcemia)
  • Currently treated with potassium-binding medications like Sodium polystyrene sulfonate or Sodium zirconium cyclosilicate
  • Currently using potassium-sparing diuretics
  • Pre-dialysis potassium below 4.0 mEq/L during the long interdialytic period
  • Receiving only one or two dialysis sessions per week
  • Poor adherence to prescribed potassium-restricted diet
  • History of bowel obstruction, major gastrointestinal surgery, severe gastrointestinal or swallowing disorders
  • Previous cardiac arrhythmias possibly related to low potassium
  • Known allergy to patiromer or any of its ingredients
  • Inability to understand study risks and benefits
  • Conditions that could prevent completing treatment or affect data, including cancer (except non-metastatic skin cancers), active autoimmune diseases, use of steroids or immunosuppressive drugs
  • Severe or unstable heart failure needing hospitalization or therapy changes in last 3 months
  • Uncontrolled severe hypertension despite treatment
  • HIV positive
  • Drug or alcohol abuse
  • Pregnancy, breastfeeding, intention to become pregnant during study or 90 days after last dose
  • Intention to donate eggs or sperm during study and 90 days after
  • Women of childbearing potential without highly effective contraception
  • Involvement in study planning or conduct
  • Participation in another investigational study within last month

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nephrology Unit, ASST Papa Giovanni XXIII

Bergamo, BG, Italy, 24127

Actively Recruiting

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Research Team

P

Piero L Ruggenenti, M.D.

CONTACT

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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