## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** Hyperkalemia treatment in HD
#### Organization
**Class:** OTHER
**Full Name:** Alexandria University
### Status Module
#### Completion Date
**Date:** 2024-06-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-18

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-15

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2023-09-08
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-01
**Study First Submit QC Date:** 2023-09-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Alexandria University

#### Responsible Party

**Investigator Affiliation:** Alexandria University

**Investigator Full Name:** Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD

**Investigator Title:** Lecturer

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Hyperkalemia

**Keywords:**

- Hyperkalemia

- Hemodialysis

- Sodium Zirconium Cyclosilicate

- Sodium Polystyrene Sulfonate

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**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 Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 30 patients will receive sodium zirconium cyclosilicate (SZC)

**Intervention Names:**

- Drug: sodium zirconium cyclosilicate (SZC)

**Label:** Group A

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 30 patients will receive sodium polystyrene sulfonate

**Intervention Names:**

- Drug: sodium polystyrene sulfonate

**Label:** Group B

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A

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

**Name:** sodium zirconium cyclosilicate (SZC)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Group B

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

**Name:** sodium polystyrene sulfonate

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Change in serum potassium

**Time Frame:** 4 weeks

#### Secondary Outcomes

**Description:** By assessing change in interdialytic weight

**Measure:** Change in interdialytic weight

**Time Frame:** 4 weeks

**Description:** By reporting any GIT SE

**Measure:** Gastrointestinal side effects

**Time Frame:** 4 weeks

**Description:** systolic and diastolic Blood pressure change

**Measure:** Change in Blood pressure

**Time Frame:** 4 weeks

**Description:** By reporting any serious adverse events.

**Measure:** Serious adverse events

**Time Frame:** 4 weeks

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dr_mohamedmamdouh87@yahoo.com

**Name:** Mohamed Mamdouh Elsayed, MD

**Phone:** 00201068055103

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Alexandria

**Contacts:**

***Contact 1:***

- **Email:** dr_mohamedmamdouh87@yahoo.com

- **Name:** Mohamed Mamdouh Elsayed, MD

- **Phone:** 00201068055103

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Faculty of Medicine, Aexandria University

**Status:** RECRUITING

**Zip:** 21526

#### Overall Officials

**Official 1:**

**Affiliation:** lecturer

**Name:** Mohamed Mamdouh Elsayed, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** consultant

**Name:** Marwa Ahmed Abdelrahman, MD

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** Lecturer

**Name:** Mohamed Aly Abdelhalim, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**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.

**PMID:** 27592170

**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.

**PMID:** 29679302

**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.

**PMID:** 28356904

**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.

**PMID:** 30675431

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014883

- Term: Water-Electrolyte Imbalance

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9998

- Name: Hyperkalemia

- Relevance: HIGH

- As Found: Hyperkalemia

- ID: M17624

- Name: Water-Electrolyte Imbalance

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006947

- Term: Hyperkalemia

### Intervention Browse Module - Ancestors

- ID: D000002614

- Term: Chelating Agents

- ID: D000064449

- Term: Sequestering Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M240546

- Name: Polystyrene sulfonic acid

- Relevance: HIGH

- As Found: Visual stimulation

- ID: M5860

- Name: Chelating Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000003321

- Term: Polystyrene sulfonic acid

### Misc Info Module

- Version Holder: 2024-05-24
