Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000983606
Ethics application status
Approved
Date submitted
5/09/2014
Date registered
12/09/2014
Date last updated
12/09/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the efficacy of colestipol for phosphate reduction in chronic kidney disease - a feasibility study
Scientific title
Evaluation of the efficacy of colestipol for phosphate reduction in haemodialysis patients - a feasibility study
Secondary ID [1] 285285 0
Nil
Universal Trial Number (UTN)
U1111-1161-1898
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperphosphataemia 292950 0
Chronic Kidney disease 293026 0
Condition category
Condition code
Renal and Urogenital 293247 293247 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a dose finding study to assess the efficacy of increasing doses of colestipol hydrochloride in patients on haemodialysis. After a successful screening procedure, eligible patients undergo a 2 week washout period when all current phosphate binding medications are stopped. After this washout period all patients with a serum phosphate that reaches 1.7 mmol/L or greater will be started on orally administered colestipol treatment. The starting dose of colestipol will vary depending on the phosphate level at the end of the washout period. Those with a phosphate level of 2.5mmol/L or higher will start on two, 1 gram tablets three times a day. Those with a phosphate level below 2.5 will start on one, 1 gram tablet three times a day. This dose will be up-titrated at two week intervals for patients who fail to achieve a target phosphate of less than 1.7mmol/L. Each increment in dose will be of one 1g tablet three times a day. The treatment period will last for 8 weeks, with three potential up-titrations, and a maximum dose of 4g three times a day. After completion of the treatment period, patients will undergo a second 2 week washout period to see if any changes in phosphate level revert to first to pre-treatment levels.
Compliance is to be monitored by returned pill counts and weekly visits and managed with protocol deviation logs.
Intervention code [1] 290183 0
Treatment: Drugs
Comparator / control treatment
There is no direct comparison group but active treatment is preceded and followed by a washout phase of previous phosphate binder treatment, in accordance with usual trial design for this type of intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293097 0
Difference in serum phosphate between end of first washout period and after 8 weeks of treatment with colestipol
Timepoint [1] 293097 0
After 8 weeks of active treatment with colestipol
Primary outcome [2] 293131 0
Difference in serum phosphate after end of active treatment and end of second washout phase
Timepoint [2] 293131 0
After second washout (2 weeks)
Secondary outcome [1] 310329 0
Difference in serum calcium end of first washout period and after 8 weeks of treatment with colestipol
Timepoint [1] 310329 0
After 8 weeks of active treatment with colestipol
Secondary outcome [2] 310420 0
Difference in lipid profile between end of first washout period and after 8 weeks of treatment with colestipol.
Lipid assay is performed on plasma samples with general assay by an Abbot kit, and HDL assay by a Roche kit.
Timepoint [2] 310420 0
After 8 weeks of active treatment with colestipol
Secondary outcome [3] 310421 0
Difference in prothrombin time between end of first washout period and after 8 weeks of treatment with colestipol.
Prothrombin time is assessed on citrated plasma by means of a standard kit.
Timepoint [3] 310421 0
After 8 weeks of active treatment with colestipol

Eligibility
Key inclusion criteria
Patients with end-stage kidney disease stable on thrice weekly haemodialysis for at least 3 months. Stable dose of phosphate binder for at least one month prior to screening, stable dose of vitamin D supplement and serum phosphate >=1.6mmol/L and <=3.5mmol/L after first washout phase.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients are excluded if they have a history of clinically significant gastrointestinal motility disorder, dysphagia or swallowing disorder, if they require warfarin or digoxin treatment, if they have a history of alcohol or substance abuse, if they need to change their dialysis prescription during the study period, if they need oral calcium, magnesium, aluminium, or iron-containing preparations during the trial other than nocturnal calcium for treating hypocalcaemia developing during the trial period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/07/2012
Actual
23/07/2012
Date of last participant enrolment
Anticipated
Actual
3/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 6336 0
New Zealand
State/province [1] 6336 0

Funding & Sponsors
Funding source category [1] 289905 0
Hospital
Name [1] 289905 0
Centre for clinical research and effective practice innovation fund
(Middlemore hospital)
Country [1] 289905 0
New Zealand
Funding source category [2] 289906 0
Charities/Societies/Foundations
Name [2] 289906 0
Maurice and Phyllis Paykel Trust
Country [2] 289906 0
New Zealand
Primary sponsor type
Individual
Name
Dr Christoper Hood
Address
Department of renal medicine,
Middlemore hospital
100 Hospital Road, Papatoetoe 2025, New Zealand
Country
New Zealand
Secondary sponsor category [1] 288594 0
Individual
Name [1] 288594 0
Dr Mark Marshall
Address [1] 288594 0
Department of renal medicine
Middlemore hospital
100 Hospital Road, Papatoetoe 2025, New Zealand
Country [1] 288594 0
New Zealand
Secondary sponsor category [2] 288595 0
Individual
Name [2] 288595 0
Dr Jamie Kendrick-Jones
Address [2] 288595 0
Department of renal medicine
Middlemore hospital
100 Hospital Road, Papatoetoe 2025, New Zealand
Country [2] 288595 0
New Zealand
Other collaborator category [1] 278147 0
Individual
Name [1] 278147 0
Dr Martin Wolley
Address [1] 278147 0
Hypertension Unit
Princess Alexandra hospital
Ipswich Rd
Woolloongabba 4102
Queensland
Country [1] 278147 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291626 0
Lower South Regional Ethics Committee
Ethics committee address [1] 291626 0
c/- Ministry of Health
229 Moray Place
Dunedin
9016
Ethics committee country [1] 291626 0
New Zealand
Date submitted for ethics approval [1] 291626 0
14/03/2011
Approval date [1] 291626 0
14/06/2011
Ethics approval number [1] 291626 0
LRS/11/02/005

Summary
Brief summary
Over 2000 New Zealanders suffer from end-stage kidney disease and require ongoing dialysis treatment. Because high phosphate levels are common in kidney disease and contribute to complications, phosphate binding drugs are needed in dialysis patients. Calcium and aluminium based drugs are most commonly used but have significant limitations, and other alternatives are expensive. Colestipol is a drug used for high cholesterol, but also may work as an alternative inexpensive phosphate binder. This trial is intended to determine the efficacy, safety and tolerability of colestipol as a phosphate binder in haemodialysis patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51222 0
Dr Christoper Hood
Address 51222 0
Department of renal medicine
Middlemore hospital
100 Hospital Road, Papatoetoe 2025, New Zealand
Country 51222 0
New Zealand
Phone 51222 0
+64 9 276 0044 ext 9605
Fax 51222 0
Email 51222 0
[email protected]
Contact person for public queries
Name 51223 0
Christoper Hood
Address 51223 0
Department of renal medicine
Middlemore hospital
100 Hospital Road, Papatoetoe 2025, New Zealand
Country 51223 0
New Zealand
Phone 51223 0
+64 9 276 0044 ext 9605
Fax 51223 0
Email 51223 0
[email protected]
Contact person for scientific queries
Name 51224 0
Christopher Hood
Address 51224 0
Department of renal medicine
Middlemore hospital
100 Hospital Road, Papatoetoe 2025, New Zealand
Country 51224 0
New Zealand
Phone 51224 0
+64 9 276 0044 ext 9605
Fax 51224 0
Email 51224 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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