End-stage Renal DiseasePhase 2/3NCT06406140
Study the Effect of Niacin on Lipoprotein (a) Concentration and Hyperphosphatemia in Hemodialysis Patients
A Phase 2/3 study testing Niacin tablets 500 mg in people with End-stage Renal Disease, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Niacin tablets 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2024to 15 Feb 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potential Effect of Niacin on Lipoprotein (a) Concentration and Hyperphosphatemia in End-Stage Renal Disease Patients Undergoing Hemodialysis
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.
Read more
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:
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).
Read the detailed description
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.
- Conditions
- End-stage Renal Disease
- Being tested
- Niacin tablets 500 mg
- Keywords
- Hemodialysis, Niacin, Lipoprotein a
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niacin tablets 500 mgDrug
Also called Niacin 500 mg
tablets used to treat hyperphosphatemia and lower lipoprotein a concentration in End-Stage Renal Disease Patients Undergoing Hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| Experimental Niacin group | Experimental | patients will receive niacin-tablets 500 mg per day with their standard therapy for 3 months. Receives: Drug: Niacin tablets 500 mg |
| control group | No intervention | patients will receive their standard therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum phosphorus level
Niacin is expected to lower serum phosphorus levels in dialysis patients
Measured: 3 months
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start15 Mar 2024
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Reda Muhammad Galal, Al-Azhar University
- Investigators
- Zeinab AlKasaby, professor, Principal investigator, Dean of Faculty of Pharmacy (Girls), Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406140
- Sponsor's protocol ID
- Interventional clinical study
- Status last verified
- Jul 2024
- First submitted
- 19 Apr 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41140700
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Effect of Niacin on Lipoprotein (a) Concentration and Hyperphosphatemia in End-Stage Renal Disease Patients Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT06406140
- Acronym / sponsor ID
- Interventional clinical study
- Conditions
- End-stage Renal Disease
- Keywords
- Hemodialysis, Niacin, Lipoprotein a
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Niacin group | Experimental | Drug: Niacin tablets 500 mgpatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niacin tablets 500 mgAlso: Niacin 500 mgtablets used to treat hyperphosphatemia and lower lipoprotein a concentration in End-Stage Renal Disease Patients Undergoing Hemodialysis | Drug | Experimental Niacin group |
Primary outcome
Change in serum phosphorus level
Time frame: 3 months
Niacin is expected to lower serum phosphorus levels in dialysis patients
1 secondary outcome
change in Lipoprotein (a) Concentration
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Derived from this study: PubMed 41140700Galal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeinab AlKasaby, professor principal investigator
Dean of Faculty of Pharmacy (Girls), Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Niacin tablets 500 mg in people with End-stage Renal Disease, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum phosphorus level (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06406140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.