None listed
Conditions
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.
Interventions
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
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.
Sponsors
Dr Christoper Hood
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Outcome results
None listed