The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06029179
Recruitment Status : Recruiting
First Posted : September 8, 2023
Last Update Posted : March 18, 2024
Sponsor:
Information provided by (Responsible Party):
Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University

Tracking Information
First Submitted Date  ICMJE September 1, 2023
First Posted Date  ICMJE September 8, 2023
Last Update Posted Date March 18, 2024
Actual Study Start Date  ICMJE January 15, 2024
Estimated Primary Completion Date May 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2023)		 Change in serum potassium [ Time Frame: 4 weeks ]
By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2023)
  • Change in interdialytic weight [ Time Frame: 4 weeks ]
    By assessing change in interdialytic weight
  • Gastrointestinal side effects [ Time Frame: 4 weeks ]
    By reporting any GIT SE
  • Change in Blood pressure [ Time Frame: 4 weeks ]
    systolic and diastolic Blood pressure change
  • Serious adverse events [ Time Frame: 4 weeks ]
    By reporting any serious adverse events.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2023)
  • Change in interdialytic weight [ Time Frame: 4 weeks ]
    By assessing change in interdialytic weight
  • Gastrointestinal side effects [ Time Frame: 4 weeks ]
    By reporting any GIT SE
  • Change in Blood pressure [ Time Frame: 4 weeks ]
    systolic and diastolic Blood pressure change
  • Serious adverse events [ Time Frame: 4 weeks ]
    By reporting any serious adverse events during and after study for 2 weeks.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients
Official Title  ICMJE Sodium Zirconium Cyclosilicate Versus Sodium Polystyrene Sulfonate for Treatment of Hyperkalemia in Hemodialysis Patients: A Randomized Clinical Trial
Brief Summary This study aims to compare the effects of Sodium Zirconium Cyclosilicate versus Sodium Polystyrene Sulfonate for treatment of hyperkalemia in patients undergoing regular hemodialysis.
Detailed Description

Patients maintained on regular hemodialysis (HD) have a high risk of hyperkalemia (>5.0 mmol/l). Hyperkalemia is a critical medical condition that can result in arrhythmias and sudden cardiac death. Treatment of hyperkalemia in HD patients is challenging.

Therapeutic options for the treatment of hyperkalemia in HD population include potassium binding resins, such as sodium polystyrene sulfonate (SPS), patiromer, and sodium zirconium cyclosilicate. There is limited data about the use of these agents in HD.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This research is a prospective randomized multicentric clinical trial in which 60 hemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1.

  • Group A: 30 patients will receive sodium zirconium cyclosilicate (SZC) 5 g once daily on non-dialysis days (15 gm/week) for 4 weeks.
  • Group B: 30 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 4 weeks.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hyperkalemia
Intervention  ICMJE
  • Drug: sodium zirconium cyclosilicate (SZC)
    30 patients will receive sodium zirconium cyclosilicate (SZC) 5 g once daily on non-dialysis days (15 gm/week) for 4 weeks.
  • Drug: sodium polystyrene sulfonate
    30 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 4 weeks.
Study Arms  ICMJE
  • Active Comparator: Group A
    30 patients will receive sodium zirconium cyclosilicate (SZC)
    Intervention: Drug: sodium zirconium cyclosilicate (SZC)
  • Active Comparator: Group B
    30 patients will receive sodium polystyrene sulfonate
    Intervention: Drug: sodium polystyrene sulfonate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 1, 2023)		 60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 15, 2024
Estimated Primary Completion Date May 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ≥3 month of maintenance hemodialysis, 3 times per week for 4 hours.
  2. Adult patients with age above 18 years.
  3. baseline serum potassium level >5 mEq/L.

Exclusion Criteria:

  1. Gastrointestinal diseases (constipation, bleeding, Hx of endoscopy, chronic diarrhea or diarrhea in the past month, malabsorption, GIT surgery, ischemic colitis, necrosis, perforation, ….).
  2. Breast feeding or pregnancy.
  3. Patients who receive medications to treat hyperkalemia 2 weeks before study.
  4. myocardial infarction, acute coronary syndrome, stroke, seizure, or thromboembolic event within 8 weeks before study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mohamed Mamdouh Elsayed, MD 00201068055103 dr_mohamedmamdouh87@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06029179
Other Study ID Numbers  ICMJE Hyperkalemia treatment in HD
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Alexandria University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohamed Mamdouh Elsayed, MD lecturer
Study Chair: Marwa Ahmed Abdelrahman, MD consultant
Study Chair: Mohamed Aly Abdelhalim, MD Lecturer
PRS Account Alexandria University
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP