Evaluation of the efficacy of colestipol for phosphate reduction in chronic kidney disease - a feasibility study

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000983606
• Date of registration: 12/09/2014
• Prospective Registration: No
• Primary sponsor: Dr Christoper Hood
• 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
• Date of first enrolment: 23/07/2012
• Target sample size: 30
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000983606.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Phase 2

Countries of recruitment

New Zealand

Contacts

• Name: Dr Christoper Hood

• Name: Dr Christopher Hood

Key inclusion & exclusion criteria

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.
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.

Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Hyperphosphataemia;Chronic Kidney disease;
Hyperphosphataemia
Chronic Kidney disease

Renal and Urogenital - Kidney disease

Intervention(s)

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.

Primary Outcome(s)

Difference in serum phosphate between end of first washout period and after 8 weeks of treatment with colestipol[After 8 weeks of active treatment with colestipol]

Difference in serum phosphate after end of active treatment and end of second washout phase[After second washout (2 weeks)]

Secondary Outcome(s)

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.[After 8 weeks of active treatment with colestipol]

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.[After 8 weeks of active treatment with colestipol]

Difference in serum calcium end of first washout period and after 8 weeks of treatment with colestipol[After 8 weeks of active treatment with colestipol]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Centre for clinical research and effective practice innovation fund (Middlemore hospital)

Maurice and Phyllis Paykel Trust

Secondary Sponsor(s)

Dr Jamie Kendrick-Jones

Dr Mark Marshall

Ethics review

Status: Approved
Approval date:
Contact:

Lower South Regional Ethics Committee