Study the Effect of Niacin on Lipoprotein (a) Concentration and Hyperphosphatemia in Hemodialysis… (NCT06406140) | Clinical Trial Compass
By InvitationPhase 2/3
Study the Effect of Niacin on Lipoprotein (a) Concentration and Hyperphosphatemia in Hemodialysis Patients
Egypt50 participantsStarted 2024-03-15
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;