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Hyperkalemia clinical trials

View clinical trials related to Hyperkalemia.

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NCT ID: NCT06281470 Completed - Hyperkalemia Clinical Trials

The Safety and Tolerability of WS016 in Healthy Chinese Volunteers

Start date: February 13, 2023
Phase: Phase 1
Study type: Interventional

This clinic trial evaluates the safety and tolerability of single- and multiple- ascending doses of WS016 in healthy adult participants. There will be about 64 participants,48 active and 16 placebo.

NCT ID: NCT06277128 Recruiting - Hyperkalemia Clinical Trials

A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia.

Start date: September 11, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy of different doses of WS016(3g, 6g and 12g) orally administered three times a day for 48 hours (acute treatment phase) vs placebo in the treatment of hyperkalemia, and to evaluate the efficacy of WS016(3g, 6g and 12g) orally administered once daily for 12 days ( maintenance treatment phase) vs placebo in maintaining normokalemia in participants have returned to normokalemia after the acute treatment phase.

NCT ID: NCT06256991 Not yet recruiting - Hypertension Clinical Trials

Potassium Correction for RAAS Optimization in Chronic Kidney Disease

PROMISE
Start date: April 2024
Phase: Phase 4
Study type: Interventional

The goal of this placebo-controlled, double-blinded cross-over trial is to test whether patiromer, compared with placebo, better enables up-titration of RAAS-blocker treatment in patients with chronic kidney disease stage 3b/4. The main questions it aims to answer are: - Does patiromer allow uptitration of irbesartan, resulting in a significant reduction in albuminuria and blood pressure? - Does patiromer allow uptitration of irbesartan, resulting in a significant reduction in blood pressure? The trial contains the following interventions: - Participants will be switched from their ACEi/ARB to a standardised dose of irbesartan (150 mg/d). - During two 12-week study periods, participants will receive either patiromer 8.4 g/d or placebo. The order of study periods is randomized. - At the start of each study period irbesartan will be up-titrated to 300 mg/d. - After 1 and 6 weeks, at both periods, plasma potassium will be measured and the irbesartan dose will be reduced to 150 mg/d in case plasma potassium exceeds 5.0 mmol/L. - At 12 weeks from the start of the study period, the endpoints will be assessed. - Between the two study periods, there is a 6-week washout. Irbesartan dose during the wash-out period will be 150mg/d. After washout, participants will switch from the patiromer arm to the placebo arm or vice versa.

NCT ID: NCT06185660 Recruiting - Hyperkalaemia Clinical Trials

A National, Multicenter, Prospective, Observational Study to Assess Patient Characteristics, Treatment Algorithms and Disease Management of Hyperkalaemia Patients With Chronic Kidney Disease or Under Dialysis or With Heart Failure, Treated With Sodium Zirconium Cyclosilicate in Greece

SHIELD
Start date: February 9, 2024
Phase:
Study type: Observational

This is a multicenter, observational, prospective, national study which includes patients with chronic kidney disease (CKD) under dialysis or not, or with heart failure (HF), treated with sodium zirconium cyclosilicate (SZC) as per Summary of Product Characteristics (SmPC), aiming to collect information on patient characteristics, routine clinical practice and treatments administered for managing hyperkalaemia in a real-world setting in Greece. It will include approximately 12 public hospital and clinic based nephrology, or cardiology sites throughout the country. Sites and investigators will be selected so to represent the management of patients with CKD under dialysis or not, or with HF receiving Renin angiotensin aldosterone inhibitors/Mineralocorticoid receptor antagonists (RAASi/MRAs) therapy, and treated with sodium zirconium cyclosilicate (SZC) as per SmPC at a national level. The final selection of the participating sites will be based on a documented feasibility evaluation process that will assess physicians' qualifications, previous participation, and experience in similar clinical studies. Data will be obtained prospectively during the study visits as performed per standard clinical practice. Data regarding the patient's medical history will be collected retrospectively from patient medical charts records. Physicians will monitor eligible patients and will record their management according to their usual clinical practice. Only medical records available from the clinical practice and provided by the physicians will be used in this study as source documentation and the data will be entered into the electronic Case Report Form. Therefore, the collected data will reflect usual clinical practice. The study will enroll approximately 120 hyperkalaemia patients with serum potassium level >5.0 mmol/L, being treated with sodium zirconium cyclosilicate for hyperkalaemia at the time of enrolment as per SmPC, assigned in a 2:1:1 ratio to one of the following 3 groups: (1) CKD patients not on dialysis (60 patients), (2) CKD patients on dialysis (30 patients) and (3) HF patients receiving RAASi/MRAs therapy (30 patients), all consisting the study population. Patients will be followed for 6 months, with a 6-month recruitment period, for a total study duration of 12 months.

NCT ID: NCT06120608 Not yet recruiting - Clinical trials for Hyperkalemia, Diminished Renal Excretion

Evidence for Potassium Restriction in Hemodialysis

EvoKe-HD
Start date: April 22, 2024
Phase: N/A
Study type: Interventional

EvoKe-HD is a pilot randomized controlled trial to assess the feasibility and potential for efficacy of a novel dietary approach to hyperkalemia. Contrary to the traditional recommendations limiting the intake of high-potassium whole foods, such as fruits and vegetables, the investigators propose to switch the focus to foods containing potassium that is readily absorbed by the body (high bioavailability), such as potassium from additives, processed meats, milk, fruit juices and sugary drinks.

NCT ID: NCT06036823 Recruiting - Hyperkalemia Clinical Trials

5 Versus 10 Units of Insulin in Hyperkalemia Management

Start date: October 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this study is to compare 5 units of intravenous Regular insulin to 10 units of intravenous regular insulin in the management of hyperkalemia. We will measure the efficacy of these 2 doses of insulin in reducing hyperkalemia at 2 hours from administration using the main laboratory serum values.

NCT ID: NCT06029179 Recruiting - Hyperkalemia Clinical Trials

SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

Start date: January 15, 2024
Phase: N/A
Study type: Interventional

This study aims to compare the effects of Sodium Zirconium Cyclosilicate versus Sodium Polystyrene Sulfonate for treatment of hyperkalemia in patients undergoing regular hemodialysis.

NCT ID: NCT05860491 Completed - Hyperkalemia Clinical Trials

Dietary Fiber and Hyperkalemia in Dialysis Patients

Start date: January 1, 2022
Phase:
Study type: Observational

To analyze the dietary nutrition and dietary fiber (DF) intake of maintenance hemodialysis (MHD) patients, and explore the effect of dietary nutrition and DF intake balance on the nutritional status and pre-dialysis hyperkalemia of MHD patients.

NCT ID: NCT05786469 Recruiting - Hyperkalemia Clinical Trials

Patiromer Trial in CKD Stage IIIB to V

Start date: August 2, 2023
Phase: Phase 3
Study type: Interventional

This phase III, prospective, randomized, double-blind, placebo-controlled trial will primarily aim to compare the effects of patiromer and placebo on the rate of withdrawal or down-titration of RAAS inhibition therapy because of refractory hyperkalemia (serum K+ levels ≥ 5.5 mEq/L at two consecutive visits, one-week apart) in non-dialysis patients with CKD stage IIIB to V receiving best available conservative therapy, including RAAS inhibition with ACE inhibitors and/or ARBs and/or aldosterone antagonists. Patients are expected to be included during an 18-month recruitment period. All randomized patients will be maintained on active follow-up for 12 months. At 12 months, a final visit will be performed for all patients who complete the follow-up period. During this final visit, all the parameters evaluated at baseline will be reassessed and the study treatment will be discontinued. Whenever feasible, a final visit will be planned within one month also for those patients who prematurely discontinue the treatment period for any intercurrent reason (adverse event, consent withdrawal and other). After the final visit the patient will be discharged from the study and will be referred to his nephrologist with the suggestion to check serum potassium levels within three days.

NCT ID: NCT05766839 Recruiting - Hyperkalemia Clinical Trials

Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age

Start date: March 2024
Phase: Phase 2
Study type: Interventional

A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia