Clinical Trials Logo

Clinical Trial Summary

This is a descriptive single arm open-label interventional trial lasting 6 weeks aiming to test if a low protein healthy K-rich diet with fruits, vegetables, whole grains, and nuts with concomitant use of new potassium binder (SZC) can be safely prescribed to patients with chronic kidney disease (CKD) stages 4 and 5 with hyperkalemia. Thirty adult CKD patients with hyperkalemia will be included. In the first 3 weeks of the study the plasma K will be normalized with the use of SZC and then the participants will receive a fruit basket during 3 weeks. SZC will be continued thru out the study. Primary end points will be changes in patient satisfaction with treatment, patient symptom list, and intake of energy and protein before and after the stabilization and healthy diet phase. Secondary outcomes will include changes in quality of life, obstipation and circulating gut microbiota-related uremic toxins.


Clinical Trial Description

Feasibility, descriptive single arm open-label interventional trial lasting 6 weeks. The study will recruit 36 CKD patients at the outpatient clinic with: age between 18 to 85 years; glomerular filtration rate < 29 ml/min/1.73 m2 and not on dialysis; serum K > 5.1 mmol/L or in previous use of sodium polystyrene sulfonate (SPS) to decrease serum K levels, and who develops hyperkalemia after SPS is ceased. Patients with serum K > 6.5 mmol/ and those likely to start dialysis within 2 months, with inflammatory bowel syndrome or with a history of hypokalemia (<3.0 mmol/L) will not be included. Primary end points will be changes in patient satisfaction with treatment, patient symptom list, and intake of energy and protein before and after the stabilization and healthy diet phase. Secondary outcomes will include changes in quality of life, obstipation and circulating gut microbiota-related uremic toxins. Intervention: In the first 3 weeks, representing stabilization phase, SZC will be prescribed to normalize plasma potassium to 3.5 to 5.0 mml/L, and a diet with energy 25-35 kcal/kg/day and protein 0.6 to 0.8 g/kg/day and with low K content will be prescribed by a renal dietitian. At the end of the first 3 weeks, the patients will be instructed to keep the diet with same content of energy and initiate a healthy diet containing 3700 to 4000 mg/potassium for 3 weeks (healthy diet phase). In order to increase adherence, a food basket containing fruits, vegetables, whole grains, nuts, white meat, fish and eggs in amounts adequate for the patient and the family will be provided. Serum K will be monitored to promote serum K between 3.5 to 5.0 mmol/L and adjustments in the dose of SZC will be performed according to the drug label. Blood measurements, questionnaires related to quality of life and intestinal obstipation and measurements of nutritional intake will be performed in the beginning and at the end of the stabilization phase and again in the beginning and end of the healthy diet phase. Additionally, during stabilization and healthy diet phases, serum K will be measured every 72 hours until serum K is normalized and after that, once per week. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04207203
Study type Interventional
Source Karolinska Institutet
Contact
Status Completed
Phase N/A
Start date November 3, 2020
Completion date May 10, 2023

See also
  Status Clinical Trial Phase
Completed NCT03172702 - Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia Phase 3
Terminated NCT05056727 - A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia Phase 3
Recruiting NCT05766839 - Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age Phase 2
Completed NCT02609841 - POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study N/A
Recruiting NCT06277128 - A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia. Phase 2
Recruiting NCT04789239 - OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure Phase 2
Completed NCT05029310 - Effects of Patiromer on Pharmacokinetics of Immunosuppresive Drugs in Renal Transplant Recipients Phase 4
Terminated NCT04443608 - Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalemia Management Phase 4
Completed NCT02607085 - REal World EVidence for TrEAtment of HyperkaLemia in Emergency Department: Multicenter, Prospective, Observational Study N/A
Completed NCT03283267 - A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS) Phase 1
Recruiting NCT06036823 - 5 Versus 10 Units of Insulin in Hyperkalemia Management Phase 4
Recruiting NCT05173584 - Levalbuterol Compared to Albuterol Regarding Cardiac Side Effects and Potassium Lowering Effects. Phase 4
Completed NCT05184998 - Description of the Clinical Outcomes of Hospitalized Patients With Heart Failure With Different Serum Potassium Levels
Completed NCT01737697 - Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia Phase 3
Completed NCT01493024 - Safety & Efficacy of Zirconium Silicate in Chronic Kidney Disease or Moderate Kidney Dysfunction With Mild Hyperkalemia Phase 2
Completed NCT05382988 - Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy Phase 3
Completed NCT04217590 - Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects Phase 3
Recruiting NCT03096561 - Measurement of Serum Potassium Rate During Accidental Hypothermia. N/A
Completed NCT03326583 - The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia Phase 2
Completed NCT03528681 - A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia. Phase 3