HyperkalaemiaChronic Kidney Disease Stage 3 and 4Dietary Intervention
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Mario Negri Institute for Pharmacological Research · Other
Who this trial is looking for
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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.
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Eligibility Criteria
Inclusion Criteria (to be eligible to participate in this trial, an individual must meet all the following criteria):
* 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…
Inclusion Criteria (to be eligible to participate in this trial, an individual must meet all the following criteria):
* 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
Exclusion Criteria (an individual who meets any of the following criteria will be excluded from participation in this trial):
* 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
* Concomitant treatment with steroids or any other immunosuppressive agent
* Severe/unstable heart failure requiring hospitalization or changes in pharmacological therapy or supplementary dialysis sessions over the last three months
* Refractory severe hypertension (BP \>180/100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications)
* Known to be positive for human immunodeficiency virus
* Drug or alcohol abuse
* Pregnancy, lactation, or intention to become pregnant before or during the study period, or within 90 days of the last dose of study treatment
* Intention to donate ova or sperm over the same period
* Childbearing potential without highly effective contraception methods according to the 2020 CTFG Recommendations related to contraception and pregnancy testing in clinical trials (https://www.hma.eu/fileadmin/dateien/Human\_Medicines/01About\_HMA/Working\_Groups/CTFG/2020\_09\_HMA\_CTFG\_Contraception\_guidance\_Version\_1.1\_updated.pdf)
* Involvement in the study planning and/or conduct
* Participation in another clinical study with an investigational product during the last month
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