BridgeMD
New treatment option for Hyperkalaemia
Official title Patiromer and Diet/hrQoL in Chronic Dialysis
ClinicalTrials.gov ID: NCT06858280
What this study is testing
What is Patiromer 8400 MG [Veltassa]?
Patiromer 8400 MG [Veltassa] is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for hyperkalaemia.
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
- 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.
- Phase 3: a large, late-stage study
- 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
- (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...
- Stable therapy (since at least 3 months) with RAS inhibitors or MRAs. No treatment with potassium sparing diuretics
You likely can't join if
- (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...
- Ongoing treatment with potassium-sparing diuretics
See the full eligibility 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
- (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...
- Involvement in the study planning and/or conduct
- Participation in another clinical study with an investigational product during the last month
The study team makes the final eligibility decision.
Where it's taking place
- Bergamo, BG, Italy
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 Bergamo, BG, Italy. 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.