HyperphosphatemiaPhase 4NAHPHNCT02836184
Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia
A Phase 4 study testing Nicotinic Acids and Calcium Carbonate in people with Hyperphosphatemia, run by Jiujiang No.1 People's Hospital at 1 site in China.
Trial summary
With calcium carbonate as the positive control drug, to observe the effectiveness and safety of nicotinic acid in hemodialysis patients with hyperphosphatemia Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- Nicotinic Acids and Calcium Carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Sep 2016
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ethnic Han live in China, End-stage renal disease（ESRD）patients treated with hemodialysis ≥ 3 months, between 18 and 80 years of age, serum phosphorus > 1.78 mmol/L, capable of giving informed consent
Who cannot join
- Be allergic to nicotinic acids, dysphagia, pregnant, current medication regimen including niacin or niacinamide active liver disease, peptic ulcer disease, full resection of parathyroid, malignancy, quit hemodialysis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiujiang NO.1 People's Hospital
Jiujiang, Jiangxi, 332000
About this study
Official title: The Efficacy and Safety of Nicotinic Acid in the Hemodialysis Patients With Hyperphosphatemia
With calcium carbonate as the positive control drug, to observe the effectiveness and safety of nicotinic acid in hemodialysis patients with hyperphosphatemia
Read the detailed description
Hyperphosphatemia is an important risk factor affecting long-term survival in patients with hemodialysis. Nicotinic acids, as well as its metabolites nicotinamide, were found to inhibit the sodium-phosphorus co-transporter on animal intestines. Several studies from other countries demonstrated that nicotinamide can reduce blood phosphorus levels in end-stage kidney disease patients. The purpose of this study was to investigate the effectiveness and safety of nicotinic acids on hyperphosphatemia in hemodialysis patients of ethnic Han live in China. The study is a prospective, randomized, double-blind, placebo-controlled crossover study. Eligible patients will be randomized to 6 wk of nicotinic acids or calcium carbonate. After a 2-wk washout period, patients switched to 6 wk of the alternative therapy. The primary measurement is the change in serum phosphorus during the whole term of each arm. Statistical analysis will be performed using two-sample paired-group t test.The significance level of the analysis was set to 0.05. All other adverse reactions will be analysed and reported, if there.
- Conditions
- Hyperphosphatemia
- Being tested
- Nicotinic Acids, Calcium Carbonate
- Keywords
- Hemodialysis,Hyperphosphatemia,Nicotinic Acids
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinic AcidsDrug
Also called Niacin
Nicotinic acids is administered at an initial dosage of 50mg four times daily in the first week. If no significant side effects detected, the dosage will be titrated to 100mg five times daily within the second week and last to the end of study.
Calcium CarbonateDrug
Also called Calcite
Calcium Carbonate 500mg per oral, twice a day
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Group treated with calcium carbonate for 6 weeks first,then switch to nicotinic acids treatment after 2 week of wash-out. Receives: Drug: Calcium Carbonate |
| nicotinic acids group | Experimental | Group treated with nicotinic acids for 6 weeks first,then switch to calcium carbonate treatment after 2 week of wash-out. Receives: Drug: Nicotinic Acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in serum phosphorus
Measured: Immediately after wash-out period and after 6 weeks of therapy.
Secondary outcomes (14)
change in serum calcium
Measured: Immediately after wash-out period and after 6 weeks of therapy.
change in serum calcium-phosphorus product
Measured: Immediately after wash-out period and after 6 weeks of therapy.
change in intact parathyroid hormone
Measured: Immediately after wash-out period and after 6 weeks of therapy.
change in alkaline phosphatase
Measured: Immediately after wash-out period and after 6 weeks of therapy.
change in platelet count
Measured: Immediately after wash-out period and after 6 weeks of therapy.
change in serum uric acid
Measured: Immediately after wash-out period and after 6 weeks of therapy.
change in serum glucose
Measured: Immediately after wash-out period and after 6 weeks of therapy.
change in total cholesterol
Measured: Immediately after wash-out period and after 6 weeks of therapy.
change in triglyceride
Measured: Immediately after wash-out period and after 6 weeks of therapy.
change in high density lipoprotein cholesterol
Measured: Immediately after wash-out period and after 6 weeks of therapy.
change in low density lipoprotein cholesterol
Measured: Immediately after wash-out period and after 6 weeks of therapy.
change in serum glutamic-pyruvic transaminase
Measured: Immediately after wash-out period and after 6 weeks of therapy.
change in glutamic oxalacetic transaminase
Measured: Immediately after wash-out period and after 6 weeks of therapy.
change in bilirubin
Measured: Immediately after wash-out period and after 6 weeks of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperphosphatemiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiujiang No.1 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoran Feng, Jiujiang No.1 People's Hospital
- Investigators
- Xiaoran Feng, MD,PHD, Principal investigator, Department of Nephrology, Jiujiang NO.1 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836184
- Sponsor's protocol ID
- 2016075
- Acronym
- NAHPH
- Status last verified
- Jul 2016
- First submitted
- 14 Jul 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Nicotinic Acid in the Hemodialysis Patients With Hyperphosphatemia
- ClinicalTrials.gov ID
- NCT02836184
- Acronym / sponsor ID
- NAHPH / 2016075
- Conditions
- Hyperphosphatemia
- Keywords
- Hemodialysis,Hyperphosphatemia,Nicotinic Acids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Jiujiang No.1 People's HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 18 Jul 2016 (estimated)
- 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.
With calcium carbonate as the positive control drug, to observe the effectiveness and safety of nicotinic acid in hemodialysis patients with hyperphosphatemia
Detailed description
Hyperphosphatemia is an important risk factor affecting long-term survival in patients with hemodialysis. Nicotinic acids, as well as its metabolites nicotinamide, were found to inhibit the sodium-phosphorus co-transporter on animal intestines. Several studies from other countries demonstrated that nicotinamide can reduce blood phosphorus levels in end-stage kidney disease patients. The purpose of this study was to investigate the effectiveness and safety of nicotinic acids on hyperphosphatemia in hemodialysis patients of ethnic Han live in China. The study is a prospective, randomized, double-blind, placebo-controlled crossover study. Eligible patients will be randomized to 6 wk of nicotinic acids or calcium carbonate. After a 2-wk washout period, patients switched to 6 wk of the alternative therapy. The primary measurement is the change in serum phosphorus during the whole term of each arm. Statistical analysis will be performed using two-sample paired-group t test.The significance level of the analysis was set to 0.05. All other adverse reactions will be analysed and reported, if there.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: Calcium CarbonateGroup treated with calcium carbonate for 6 weeks first,then switch to nicotinic acids treatment after 2 week of wash-out. |
| nicotinic acids group | Experimental | Drug: Nicotinic AcidsGroup treated with nicotinic acids for 6 weeks first,then switch to calcium carbonate treatment after 2 week of wash-out. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ethnic Han live in China, End-stage renal disease（ESRD）patients treated with hemodialysis ≥ 3 months, between 18 and 80 years of age, serum phosphorus > 1.78 mmol/L, capable of giving informed consent
Key exclusion criteria (1 listed)
- Be allergic to nicotinic acids, dysphagia, pregnant, current medication regimen including niacin or niacinamide active liver disease, peptic ulcer disease, full resection of parathyroid, malignancy, quit hemodialysis
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 |
|---|---|---|
| Nicotinic AcidsAlso: NiacinNicotinic acids is administered at an initial dosage of 50mg four times daily in the first week. If no significant side effects detected, the dosage will be titrated to 100mg five times daily within the second week and last to the end of study. | Drug | nicotinic acids group |
| Calcium CarbonateAlso: CalciteCalcium Carbonate 500mg per oral, twice a day | Drug | control group |
Primary outcome
change in serum phosphorus
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
14 secondary outcomes
change in serum calcium
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in serum calcium-phosphorus product
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in intact parathyroid hormone
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in alkaline phosphatase
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in platelet count
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in serum uric acid
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in serum glucose
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in total cholesterol
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in triglyceride
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in high density lipoprotein cholesterol
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in low density lipoprotein cholesterol
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in serum glutamic-pyruvic transaminase
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in glutamic oxalacetic transaminase
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
change in bilirubin
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- 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.
Xiaoran Feng, MD,PHD principal investigator
Department of Nephrology, Jiujiang NO.1 People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotinic Acids and Calcium Carbonate in people with Hyperphosphatemia, run by Jiujiang No.1 People's Hospital at 1 site in China.
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 1 inclusion and 1 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 30 Aug 2016. 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 China. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Xiaoran Feng, MD,PHD (+86 13907920138, fxr0325@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in serum phosphorus (time frame: Immediately after wash-out period and after 6 weeks of therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2016.