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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:
Participants will:
All Patients will be subjected to the following:
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).
Chronic kidney disease (CKD) is a clinical syndrome secondary to the definitive change in function and/or structure of the kidney and is characterized by its irreversibility and slow and progressive evolution. CKD is very prevalent in the general adult population .End-stage renal disease (ESRD) was defined as a need for renal replacement therapy, CKD stage G5 (estimated glomerular filtration rate ≤ 15 mL/min per 1.73 m2) .Niacin (generic name of nicotinic acid), also known as vitamin B3, is a naturally occurring water-soluble vitamin that is essential in different biological activities. The active phosphate transport inhibitors are the newest interesting agents in the management of hyperphosphatemia alone or as add-on therapy to the existing phosphate binders. Niacin is one of this novel drug classes that has been demonstrated to show promising therapeutic potential in the treatment of hyperphosphatemia in HD patients.The aim of this study is to evaluate the effect of administration of niacin on lipoprotein (a) concentration and hyperphosphatemia, which represent strong risk factors for cardiovascular diseases, in ESRD patients undergoing hemodialysis.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Niacin group | Experimental | patients will receive niacin-tablets 500 mg per day with their standard therapy for 3 months. |
|
| control group | No Intervention | patients will receive their standard therapy only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niacin tablets 500 mg | Drug | tablets used to treat hyperphosphatemia and lower lipoprotein a concentration in End-Stage Renal Disease Patients Undergoing Hemodialysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum phosphorus level | Niacin is expected to lower serum phosphorus levels in dialysis patients | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in Lipoprotein (a) Concentration | Lipoprotein (a) , which has been suggested to play a role as an independent risk factor for coronary heart disease, is expected to be decreased by niacin | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeinab AlKasaby, professor | Dean of Faculty of Pharmacy (Girls), Al-Azhar University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Azhar University | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41140700 | Derived | 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. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D009525 | Niacin |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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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.
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|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |