Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406140
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-09
First Post:
2024-04-19
Brief Title:
Study the Effect of Niacin on Lipoprotein a Concentration and Hyperphosphatemia in Hemodialysis Patients
Sponsor:
Al-Azhar University
Organization:
Al-Azhar University
Study Overview
Official Title:
Potential Effect of Niacin on Lipoprotein a Concentration and Hyperphosphatemia in End-Stage Renal Disease Patients Undergoing Hemodialysis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
1 Informed consent
2 Demographics and history taking Using Patient Data sheet
3 Laboratory evaluation including
Kidney function tests blood ureaserum creatinine albumin uric acid Complete blood count CBC Lipid profileLipoprotein atotal cholesteroltriglyceridehigh density lipoprotein HDL low density lipoprotein LDL
Phosphorous calcium sodium parathyroid hormone PTH alkaline phosphatase ALP
C-reactive protein CRP
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 ureaserum creatinine albumin uric acid Complete blood count CBC Lipid profileLipoprotein atotal cholesteroltriglyceridehigh density lipoprotein HDL low density lipoprotein LDL
Phosphorous calcium sodium parathyroid hormone PTH alkaline phosphatase ALP
C-reactive protein CRP
Detailed Description:
Chronic kidney disease CKD is a clinical syndrome secondary to the definitive change in function andor 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 mLmin per 173 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 patientsThe 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 hemodialysisPatients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None