Study the Effect of Niacin on Lipoprotein (a) Concentration and Hyperphosphatemia in Hemodialysis Patients

NCT06406140 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: Interventional clinical study
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if Niacin has an effect on lipoprotein (a) concentration and hyperphosphatemia, which represent strong risk factors for cardiovascular diseases, in End-stage renal disease (ESRD) patients undergoing hemodialysis. It will also learn about the safety of Niacin. The main questions it aims to answer are:

• Does Niacin lower lipoprotein (a) concentration?
• Does Niacin treat hyperphosphatemia in End-stage renal disease (ESRD) patients undergoing hemodialysis? Researchers will compare Niacin to a control group (taking no drug) to see if drug Niacin works to treat hyperphosphatemia and lower lipoprotein (a) concentration. Participants will:
• Take drug Niacin or no drug every day for 3 months
• Visit the clinic once every 2 weeks for checkups and tests All Patients will be subjected to the following:
• Informed consent.
• Demographics and history taking: Using Patient Data sheet.
• Laboratory evaluation including:

Conditions

End-stage Renal Disease

Keywords

Hemodialysis; Niacin; Lipoprotein a

Outcome Measures

Primary Outcomes (1)

• Change in serum phosphorus level

  Niacin is expected to lower serum phosphorus levels in dialysis patients

  3 months

Secondary Outcomes (1)

• change in Lipoprotein (a) Concentration

  3 months

Study Arms (2)

Experimental Niacin group

EXPERIMENTAL

patients will receive niacin-tablets 500 mg per day with their standard therapy for 3 months.

Drug: Niacin tablets 500 mg

control group

NO INTERVENTION

patients will receive their standard therapy only

Interventions

Niacin tablets 500 mg DRUG

tablets used to treat hyperphosphatemia and lower lipoprotein a concentration in End-Stage Renal Disease Patients Undergoing Hemodialysis

Also known as: Niacin 500 mg

Experimental Niacin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with ESRD, on maintenance hemodialysis for at least three (3) months.
• Aged 18 years or older.
• Both sexes.
• No known contraindications to therapy with niacin.
• Patients who accept to participate in the study.

You may not qualify if:

• Pregnant and breast-feeding women
• Any patient with a medical condition or taking any medications that would be contraindicated with the use of extended release niacin, such as active peptic ulcer disease;
• History of severe allergic reactions to the study medication.
• History of active infection or acute gouty attack within 2 weeks prior to enrollment;
• Current medication regimen including niacin.
• Chronic liver disease
• Patients who had received immunosuppressive therapy
• Non-compliant patients: those who did not adhere to the medications during the study.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al Azhar University

Cairo, Egypt

Location

Related Publications (1)

• Galal ARM, Salah MAR, Binsaleh AY, Alsubaie N, Alrossies AS, Elthakaby AH, Elsawy GM, Ali AA, Zalat ZAK. Targeting cardiovascular and metabolic risk modification in end stage renal disease (ESRD): a randomized controlled clinical trial on niacin's effects on lipoprotein(a) and biochemical markers in hemodialysis patients. Front Med (Lausanne). 2025 Oct 9;12:1625417. doi: 10.3389/fmed.2025.1625417. eCollection 2025.

  PMID: 41140700 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Niacin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Zeinab AlKasaby, professor

  Dean of Faculty of Pharmacy (Girls), Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Patients will be randomized into two groups each group includes 25 patients: Control group: 25 patients will receive their standard therapy only. Intervention group (niacin group): 25 patients will receive niacin 500 mg per day with their standard therapy for 3 months.

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 9, 2024
• Study Start: March 15, 2024
• Primary Completion: January 15, 2026
• Study Completion: February 15, 2026
• Last Updated: January 31, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)