Patiromer and Diet/hrQoL in Chronic Dialysis

NCT06858280 | Recruiting Phase 3

• 2 other identifiers: PRINCE2025-521378-33-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hyperkalaemia; Chronic Kidney Disease Stage 3 and 4; Dietary Intervention

Outcome Measures

Primary Outcomes (1)

• Serum potassium levels

  Change in serum potassium levels of 0.5mEq/L compared to baseline

  Before every dialysis session for 12 weeks after recruitment

Study Arms (2)

Patiromer

EXPERIMENTAL

Participants will be stratified according to the number of weekly dialysis sessions (2 vs 3) and within each stratum, and will be randomized on 1:1 basis to 3-month treatment with patiromer.

Drug: Patiromer 8400 MG [Veltassa]

Placebo

PLACEBO COMPARATOR

Participants will be stratified according to the number of weekly dialysis sessions (2 vs 3) and within each stratum, and will be randomized on 1:1 basis to 3-month treatment with the placebo.

Drug: Placebo

Interventions

Patiromer 8400 MG [Veltassa] DRUG

Randomized patients will receive one 8.4 g packet of patiromer per day or one identical packet containing a placebo. To minimize the possibility of interference with gastrointestinal absorption of other orally administered medications, administration of patiromer will be separated by at least 3 hours from other oral medicinal products. Throughout the whole study period, the study drug will be administered every day in the morning.

Patiromer

Placebo DRUG

Randomized patients will receive one packet of placebo identical to that of patiromer. Following the same treatment sequence of patiromer, administration of the placebo will be separated by at least 3 hours from any other oral medicinal products. As for patiromer, the placebo will be administered every day in the morning.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• More than 18-year-old
• Chronic and stable dialysis therapy with three weekly dialysis sessions for at least three months because of ESKD
• Pre-dialysis (in the long interdialytic period) serum potassium 4 to 5.5 mEq/L confirmed in two consecutive weeks, without any clinical signs or symptoms of hyperkalemia
• Stable therapy (since at least 3 months) with RAS inhibitors or MRAs. No treatment with potassium sparing diuretics
• On standardized and stable (moderately or strictly restricted) low-potassium diet
• Compliance with recommended diet
• Written informed consent

You may not qualify if:

• Hyperkalemia (pre-dialysis potassium \>5.5 mEq/L during the long interdialytic period)
• Hypomagnesemia (serum magnesium \<1.7 mg/dL)
• Hypercalcemia (serum calcium \>10.5mg/dl)
• Ongoing treatment with potassium binding medications including Sodium polystyrene sulfonate (SPS, Kayexalate®, Sanofi-Aventis S.p.A) or Sodium zirconium cyclosilate (Lokelma®, Astra Zeneca S.p.A.)
• Ongoing treatment with potassium-sparing diuretics
• Pre-dialysis potassium \<4.0 mEq/L during the long interdialytic period
• One or two weekly dialysis session
• Poor compliance to prescribed potassium-restricted diet
• History of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders
• Previous history of cardiac arrhythmias potentially related to hypokalemia
• Known hypersensitivity to the active ingredient or any of the excipients of the study drug
• Inability to fully understand the potential risks and benefits related to study participation
• Concomitance of clinical conditions that could jeopardize the completion of the treatment period and/or confound data interpretation including:
• Cancer (except non-metastatic cutaneous cancers)
• Active systemic autoimmune diseases

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (1)

Nephrology Unit, ASST Papa Giovanni XXIII

Bergamo, BG, 24127, Italy

RECRUITING

MeSH Terms

Conditions

Hyperkalemia; Renal Insufficiency, Chronic

Interventions

patiromer

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Piero L Ruggenenti, M.D.

CONTACT

+390352673814; pruggenenti@asst-pg23.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Placebo-controlled, single-center, pilot trial

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)