Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201905507865682 Date of Approval: 06/05/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PUBLIC TITLE ; Effect of niacin on hyperphosphatemia in chronic kidney disease (stages 3-5) patients
Official scientific title Effect of niacin on hyperphosphatemia in chronic kidney disease (stages 3-5) patients. A randomized double blind placebo controlled trial.
Brief summary describing the background and objectives of the trial Patients with end-stage renal disease commonly present with hyperphosphatemia, which is known to be associated with poor outcomes and mortality in chronic kidney disease (CKD) stages 3-5 and in non-CKD patients. It is an important risk factor for secondary hyperparathyroidism and cardiovascular disease. Kidney Disease Improving Global Outcomes (KDIGO) therefore suggest lowering elevated phosphorus levels toward the normal range in patients with CKD stages 3-5. The use of phosphate binders in reducing the amount of dietary phosphorus absorbed from the intestine is of great importance because dietary phosphorus restriction and removal of phosphorus by dialysis are usually inadequate for controlling serum phosphate. Unacceptable adverse effects such as hypercalcemia from calcium based phosphate binders, potential toxicities from aluminium based phosphate binders and the high cost of other phosphate binders (sevelamer and lanthanum carbonate) are reasons why they are not considered optimal for treating hyperphosphatemia. Phosphate lowering agents that overcome some of the defects of current therapy are thus needed. Reports from clinical trials have shown that niacin accomplish obvious reductions in serum phosphate in CKD (stages 3-5 ) patients by reducing sodium-phosphate 2b transporter expression and inhibiting intestinal phosphorus absorption . It has also been used to increase high density lipoprotein (HDL) cholesterol and reduce triglyceride levels. PRIMARY OBJECTIVE ; To determine the effect of co-administration of niacin and other phosphate binders on serum phosphate levels in the study population , compared to administration of conventional phosphate binders alone SECONDARY OBJECTIVES ; • To determine to what extent niacin affects serum lipids (HDL,LDL and Tryglycerides), calcium and calcium phosphate products ,in patients with CKD stages 3-5. • To determine the frequency and pattern of adverse effects in the study population
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 29/04/2019
Actual trial start date
Anticipated date of last follow up 28/10/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group niacin The participants will swallow one 500mg tablet daily for 4 weeks.this will be increased to 1g daily for another 4 weeks 8 weeks There will be a six (6) weeks recruitment period during which participants who meet the selection criteria will be recruited consecutively using a simple random sampling method until the minimum sample size is obtained. They will be duely screened and randomized at the last week. Experiment group will be on tabs niacin as described above. Control group will be on placebo with same duration, after which , patients will undergo a 2-week washout period, followed by 8 weeks of the alternative therapy (from niacin to placebo, and vice versa). 60
Control Group placebo 500mg tablet will be taken daily for 4 weeks ,then increased to 1g daily for another 4 weeks 8 weeks The participants will swallow one 500mg tablet daily for 4 weeks.this will be increased to 1g daily for another 4 weeks after which , patients will undergo a 2-week washout period, followed by 8 weeks of the alternative therapy (from placebo to niacin, and vice versa 60 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria CKD stages 3-5 patients who are aged 18 years -80 years. Capable of giving informed consent Serum phosphate levels 5-7 mg/dl Unchanged treatment protocol (calcium carbonate and vitamin D) during last 2 weeks. Unwillingness to participate in the study. Pregnancy Known liver disease, Active peptic ulcer disease Necessity of changing treatment protocol because of safety criteria (such as severe hyperphosphatemia or two consecutive serum phosphorus levels > 7 mg/dl) Age greater than 80 years Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/06/2018 Delta state university teaching hospital health research ethics committee
Ethics Committee Address
Street address City Postal code Country
c/o Department of surgery ,DELSUTH, Oghara Oghara 331101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean change in serum phosphate levels from first to last week Baseline,3rd,4th,5th,6th and 7th visits
Secondary Outcome Secondary outcome Mean change in calcium, calcium-phosphate products and lipid profile parameters (HDL,LDL,TRYGLICERIDES From first to last visit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Delta state university teaching hospital Department of internal medicine , DELSUTH ,Oghara Oghara 331101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded dept of internal medicine, DELSUTH,Oghara Oghara 331101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Edema Oritseweyinmi Great Dept of internal medicine, DELSUTH, Oghara Warri 331101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Offiah Chigozie department of internal medicine, DELSUTH, Oghara Oghara 331101 Nigeria
Onyebolise Stanley Department of internal medicine ,DELSUTH ,Oghara Oghara 331101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oritseweyinmi Edema edemagreat44@gmail.com +2349077271916 Dept of internal medicine,DELSUTH ,Oghara
City Postal code Country Position/Affiliation
Warri 332213 Nigeria Principal investigator
Role Name Email Phone Street address
Public Enquiries Chigozie Offiah offiahchigozie@gmail.com +2348067668353 Dept of Internal Medinine ,DELSUTH , Oghara,
City Postal code Country Position/Affiliation
Oghara 331101 Nigeria Research Assistant
Role Name Email Phone Street address
Public Enquiries Chigozie Offiah offiahchigozie@gmail.com +2348067668353 Dept of Internal mMedicine,DELSUTH, Oghara
City Postal code Country Position/Affiliation
oghara 331101 Nigeria Research Assistant
Role Name Email Phone Street address
Scientific Enquiries Oritseweyinmi Edema edemagreat44@gmail.com +2349077271916 Dept of internal medicine,DELSUTH,Oghara
City Postal code Country Position/Affiliation
Warri 332213 Nigeria Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Paticipants will be informed that results/data of the trial will be published Data on the effect of niacin on serum phosphate,calcium, lipids and adverse events will be shared Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within six months after the end of the trial Participants information documents will be provided Source document will be the participants CASE REPORT FORM which will only identify patients by their study participation number
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information