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

NCT06406140 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-01-31

No results posted yet for this study

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:

1. Informed consent.
2. Demographics and history taking: Using Patient Data sheet.
3. Laboratory evaluation including:

Kidney function tests: blood urea,serum creatinine, albumin ,uric acid. Complete blood count (CBC). Lipid profile:Lipoprotein (a),total cholesterol,triglyceride,high density lipoprotein (HDL), low density lipoprotein (LDL).

Phosphorous, calcium, sodium, parathyroid hormone (PTH), alkaline phosphatase (ALP).

C-reactive protein (CRP).

Conditions

  • End-stage Renal Disease

Interventions

DRUG

Niacin tablets 500 mg

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

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Principal Investigators

  • Zeinab AlKasaby, professor · Dean of Faculty of Pharmacy (Girls), Al-Azhar University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2026-01-15
Completion
2026-02-15
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06406140 on ClinicalTrials.gov