Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000437066
Ethics application status
Approved
Date submitted
25/05/2010
Date registered
28/05/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
“Effect of acid suppression on the effectiveness of phosphate binders in haemodialysis patients”
Scientific title
The effect of Pantoprazole in comparison to placebo on phosphate control in haemodialysis patients taking phosphate binders.
Secondary ID [1] 251861 0
none
Universal Trial Number (UTN)
U1111-1114-6844
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperphosphataemia 257165 0
Kidney disease 257484 0
Condition category
Condition code
Renal and Urogenital 257314 257314 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pantoprazole 40 mg once daily Will be administered as oral capsule for two consecutive six-week study periods (2 week run in period + 4 week data collection period) making a total of 12 weeks. Two week run in period will be considered after the end of the first 6 week study period before any data collection.
Intervention code [1] 256312 0
Treatment: Drugs
Comparator / control treatment
40 mg microcellulose capsule will be used as placebo. it will be administered as oral capsule for two consecutive six-week study periods (2 week run in period + 4 week data collection period) making a total of 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 258221 0
The difference in mean pre-dialysis plasma phosphate levels for each patient during the period on and off pantoprazole therapy
Timepoint [1] 258221 0
The pre-dialysis phosphate concentrations will be collected for each patient at the mid week dialysis at two weekly intervals for 12 weeks duration of the study.
Secondary outcome [1] 263877 0
Change in serum calcium concentration
Timepoint [1] 263877 0
The serum calcium concentrations will be collected for each patient at the mid week dialysis at two weekly intervals for 12 weeks duration of the study.
Secondary outcome [2] 263878 0
Change in the mean 7-point Global Overall Symptom (GOS28) scale.
Timepoint [2] 263878 0
Before trial entry and at the end of each 6-week study period

Eligibility
Key inclusion criteria
1- Currently receiving haemodialysis treatment for >1 month at The Queen Elizabeth Hospital, The Royal Adelaide Hospital, or affiliated satellite dialysis units (stable regimen during study period).
2- Patient receiving single agent phosphate binders (stable regimen during study period).
This include: Calcium Carbonate, Lanthanum Carbonate, Sevelamer hydrochloride, Aluminum Hydroxide.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- < 18 years of age.
2- Patients unable to give informed consent.
3- Patients enrolled in other investigational drug treatments
4- Patients deemed unable to comply with treatment regime.
5- Home dialysis patients.
6- Peritoneal dialysis patients.
7- Severe indication for acid suppression where withdrawal of acid suppression therapy is deemed unacceptable by the caring physician. (e.g.)
a- Major active peptic ulcer diseases
b- Major recent gastrointestinal bleeding
C- Major Gastro-Oesophageal Reflux Disease (GORD)
d- Major gastro-intestinal problems on 7-point Global Overall Symptom (GOS28) scale.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After the subject is evaluated by investigators and considered elgible for participation in the study, He/she will be given a Patient information sheet and will be asked to sign an informed concent form if decided to enroll in the study.
Allocation concealment will be carried out through contacting the central pharmacy clinical trial pharmacist who will be holding the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The block randomisation will be used to generate the sequence to ensure we will get a blanced number of subjects in each study group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2909 0
5011
Recruitment postcode(s) [2] 2910 0
5112
Recruitment postcode(s) [3] 2911 0
5000

Funding & Sponsors
Funding source category [1] 257048 0
University
Name [1] 257048 0
King Saud University
Country [1] 257048 0
Saudi Arabia
Primary sponsor type
University
Name
King Saud University
Address
King Saud University
BOX 2454
Riyadh 11451
Kingdom of Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 256306 0
None
Name [1] 256306 0
Address [1] 256306 0
Country [1] 256306 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259059 0
The Ethics of Human Research Committe
Ethics committee address [1] 259059 0
Ethics of Human Research Committee,
The Queen Elizabeth Hopsital,
28 Woodville Road,
Woodville South,
South Austrlia 5011
Ethics committee country [1] 259059 0
Australia
Date submitted for ethics approval [1] 259059 0
Approval date [1] 259059 0
30/04/2010
Ethics approval number [1] 259059 0
Ethics committee name [2] 259060 0
Research Ethics Committee
Ethics committee address [2] 259060 0
Research Ethics Committee,
Level 3, Hanson Institute,
The Royal Adelaide Hospital,
North Terrace,
Adelaide,
South Australia 5000
Ethics committee country [2] 259060 0
Australia
Date submitted for ethics approval [2] 259060 0
Approval date [2] 259060 0
13/05/2010
Ethics approval number [2] 259060 0

Summary
Brief summary
Hyperphosphatemia (high phosphate concentration in the blood) is common in dialysis patients. Hyperphosphatemia can cause renal bone disease and is also associated with higher mortality.

Most dialysis patients are prescribed phosphate binder drugs to bind phosphate in the gut and prevent its absorption. These include Calcium Carbonate (Caltrate (Registered Trademark) or Calsup (Registered Trademark)), Aluminium Hydroxide (Alu-Tab (Registered Trademark)), Lanthanum Carbonate (Fosrenol (Registered Trademark)) and Sevelamer (Renagel (Registered Trademark)). In theory some phosphate binder drugs need the stomach to be acidic to work effectively and bind phosphate.

Haemodialysis patients are often prescribed gastric acid suppressant drugs to treat gastric ulcers and gastric reflux disease (heartburn). These drugs include Pantoprazole (Somac (Registered Trademark)), Omeprazole (Losec (Registered Trademark)) and Esomperazole (Nexium (Registered Trademark)). These acid suppressing drugs may reduce stomach acidity and therefore the effectiveness of phosphate binders. This potential drug interaction may worsen hyperphosphatemia

The primary purpose of this study to evaluate the effectiveness of phosphate binders in managing hyperphosphataemia when they are co-administered with acid suppressive therapy in haemodialysis patients
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31053 0
Address 31053 0
Country 31053 0
Phone 31053 0
Fax 31053 0
Email 31053 0
Contact person for public queries
Name 14300 0
Ahmed Shaman
Address 14300 0
University of South Australia
City East Campus
North Terrace
Adelaide SA 5000
Country 14300 0
Australia
Phone 14300 0
(+61) 0403089891
Fax 14300 0
Email 14300 0
[email protected]
Contact person for scientific queries
Name 5228 0
Ahmed Shaman
Address 5228 0
University of South Australia
City East Campus
North Terrace
Adelaide SA 5000
Country 5228 0
Australia
Phone 5228 0
(+61) 0403089891
Fax 5228 0
Email 5228 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

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