BridgeMD
New treatment option for Chronic Kidney Diseases
Official title Keeping RAASi Treatment With Optimal Potassium Control
ClinicalTrials.gov ID: NCT06578533
What this study is testing
What is Sodium Zirconium Cyclosilicate?
Sodium Zirconium Cyclosilicate is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic kidney diseases.
Also referred to as Lokelma.
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
- Phase III, multicenter, randomized, open-label, parallel-group, non-inferiority, phase III clinical trial comparing CSZ (Lokelma) vs. iSRAA discontinuation/reduction and/or ARM (standard treatment).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- Patients must present serum potassium levels of 5.5-6.5 mEq/L at patient selection visit (V0)
- Patients must present serum potassium levels of 5.0-6.5 mEq/L at randomization visit (V1).
- Provision of patient or legal representative informed consent prior to any study specific procedures.
- Individuals receiving background standard of care for HF and treated according to locally recognized guidelines. Specific treatment should include...
- Patients with CKD not on dialysis (Stages 2-5: estimated glomerular filtration rate (eGFR) between 15-60 ml/min/1,73m2 or eGFR between 60-90 ml/min/...
You likely can't join if
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
- Previous enrollment or randomization in the present study.
- HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary...
- Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack...
- Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting or valvular repair/replacement within 12 weeks...
- Implantation of a Cardiac Resynchronization Therapy (CRT) device or Implantable Cardioverter Defibrillator (ICD) within 12 weeks prior to enrollment...
See the full eligibility criteria
- Patients must present serum potassium levels of 5.5-6.5 mEq/L at patient selection visit (V0)
- Patients must present serum potassium levels of 5.0-6.5 mEq/L at randomization visit (V1).
- Provision of patient or legal representative informed consent prior to any study specific procedures.
- Individuals receiving background standard of care for HF and treated according to locally recognized guidelines. Specific treatment should include RAASi and/or MRA treatment at first consultation and at least should...
- Patients with CKD not on dialysis (Stages 2-5: estimated glomerular filtration rate (eGFR) between 15-60 ml/min/1,73m2 or eGFR between 60-90 ml/min/ 1.73 m2 with albuminuria/creatinuria (\> 30 mg/g) in the previous...
- 18 years at the time of signing ICF.
- Negative pregnancy test (urine or serum) for female people of childbearing potential.
- Female people must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide)...
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
- Previous enrollment or randomization in the present study.
- HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease.
- Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrollment.
- Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting or valvular repair/replacement within 12 weeks prior to enrollment or planned to undergo any of these operations after...
- Implantation of a Cardiac Resynchronization Therapy (CRT) device or Implantable Cardioverter Defibrillator (ICD) within 12 weeks prior to enrollment or intent to perform atrial fibrillation ablation or to implant a CRT...
- Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or transplantation or implantation expected after randomization
- Oropharingeal dysfunction that precludes normal swallow.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
- Patients with amputated limbs or pacemaker devices will be excluded of bioimpedance analysis.
- Participation in another clinical study with an investigational product during the last 6 months.
- Patients with a known hypersensitivity to SZC or any of the excipients of the product.
- Treated with potassium binding resins such as sodium polystyrene sulfonate (SPS; e.g. Kayexalate®) or calcium polystyrene sulfonate (CPS; e.g. Resonium®) or the cation exchange polymer, patiromer sorbitex calcium...
- Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
- people with a family history of long QT syndrome, presence of cardiac arrhythmias or conduction defects that require immediate treatment, or a QTc (corrected QT interval) of ≥ 550 msec.
- History of QT prolongation associated with other medications that required discontinuation of that medications.
- Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. people with atrial fibrillation controlled by medication are permitted.
The study team makes the final eligibility decision.
Where it's taking place
- Alicante, Spain
- Barcelona, Spain
- Madrid, Spain
- Valencia, Spain
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Alicante, Spain; Barcelona, Spain; Madrid, Spain; Valencia, Spain. 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.