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SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

Primary Purpose

Hyperkalemia

Status

Not yet recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

sodium zirconium cyclosilicate (SZC)

sodium polystyrene sulfonate

About this trial

This is an interventional treatment trial for Hyperkalemia focused on measuring Hyperkalemia, Hemodialysis, Sodium Zirconium Cyclosilicate, Sodium Polystyrene Sulfonate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥3 month of maintenance hemodialysis, 3 times per week for 4 hours. Adult patients with age above 18 years. baseline serum potassium level >5 mEq/L. Exclusion Criteria: Gastrointestinal diseases (constipation, bleeding, Hx of endoscopy, chronic diarrhea or diarrhea in the past month, malabsorption, GIT surgery, ischemic colitis, necrosis, perforation, ….). Breast feeding or pregnancy. Patients who receive medications to treat hyperkalemia 2 weeks before study. myocardial infarction, acute coronary syndrome, stroke, seizure, or thromboembolic event within 8 weeks before study.

Sites / Locations

Faculty of Medicine, Aexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group A

Group B

Arm Description

30 patients will receive sodium zirconium cyclosilicate (SZC)

30 patients will receive sodium polystyrene sulfonate

Outcomes

Primary Outcome Measures

Change in serum potassium

By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval

Secondary Outcome Measures

Change in interdialytic weight

By assessing change in interdialytic weight

Gastrointestinal side effects

By reporting any GIT SE

Change in Blood pressure

systolic and diastolic Blood pressure change

Serious adverse events

By reporting any serious adverse events.

Full Information

NCT ID

NCT06029179

First Posted

September 1, 2023

Last Updated

September 7, 2023

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT06029179

Brief Title

SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

Official Title

Sodium Zirconium Cyclosilicate Versus Sodium Polystyrene Sulfonate for Treatment of Hyperkalemia in Hemodialysis Patients: A Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 15, 2023 (Anticipated)

Primary Completion Date

November 15, 2023 (Anticipated)

Study Completion Date

December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperkalemia

Keywords

Hyperkalemia, Hemodialysis, Sodium Zirconium Cyclosilicate, Sodium Polystyrene Sulfonate

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

30 patients will receive sodium zirconium cyclosilicate (SZC)

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

30 patients will receive sodium polystyrene sulfonate

Intervention Type

Drug

Intervention Name(s)

sodium zirconium cyclosilicate (SZC)

Intervention Description

30 patients will receive sodium zirconium cyclosilicate (SZC) 5 g once daily on non-dialysis days (15 gm/week) for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

sodium polystyrene sulfonate

Intervention Description

30 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 4 weeks.

Primary Outcome Measure Information:

Title

Change in serum potassium

Description

By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Change in interdialytic weight

Description

By assessing change in interdialytic weight

Time Frame

4 weeks

Title

Gastrointestinal side effects

Description

By reporting any GIT SE

Time Frame

4 weeks

Title

Change in Blood pressure

Description

systolic and diastolic Blood pressure change

Time Frame

4 weeks

Title

Serious adverse events

Description

By reporting any serious adverse events.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed Mamdouh Elsayed, MD

Phone

00201068055103

dr_mohamedmamdouh87@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed Mamdouh Elsayed, MD

Organizational Affiliation

lecturer

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marwa Ahmed Abdelrahman, MD

Organizational Affiliation

consultant

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mohamed Aly Abdelhalim, MD

Organizational Affiliation

Lecturer

Official's Role

Study Chair

Facility Information:

Facility Name

Faculty of Medicine, Aexandria University

City

Alexandria

ZIP/Postal Code

21526

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohamed Mamdouh Elsayed, MD

Phone

00201068055103

dr_mohamedmamdouh87@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

27592170

Citation

Yusuf AA, Hu Y, Singh B, Menoyo JA, Wetmore JB. Serum Potassium Levels and Mortality in Hemodialysis Patients: A Retrospective Cohort Study. Am J Nephrol. 2016;44(3):179-86. doi: 10.1159/000448341. Epub 2016 Sep 3.

Results Reference

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PubMed Identifier

29679302

Citation

Hoppe LK, Muhlack DC, Koenig W, Carr PR, Brenner H, Schottker B. Association of Abnormal Serum Potassium Levels with Arrhythmias and Cardiovascular Mortality: a Systematic Review and Meta-Analysis of Observational Studies. Cardiovasc Drugs Ther. 2018 Apr;32(2):197-212. doi: 10.1007/s10557-018-6783-0.

Results Reference

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PubMed Identifier

28356904

Citation

Beccari MV, Meaney CJ. Clinical utility of patiromer, sodium zirconium cyclosilicate, and sodium polystyrene sulfonate for the treatment of hyperkalemia: an evidence-based review. Core Evid. 2017 Mar 23;12:11-24. doi: 10.2147/CE.S129555. eCollection 2017. Erratum In: Core Evid. 2019 Feb 27;14:1.

Results Reference

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PubMed Identifier

30675431

Citation

Fried L, Kovesdy CP, Palmer BF. New options for the management of chronic hyperkalemia. Kidney Int Suppl (2011). 2017 Dec;7(3):164-170. doi: 10.1016/j.kisu.2017.09.001. Epub 2017 Nov 17.

Results Reference

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SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

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