Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000320651
Ethics application status
Approved
Date submitted
13/03/2014
Date registered
26/03/2014
Date last updated
26/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Allopurinol in Chronic Kidney Disease Patients
Scientific title
The Effects of Allopurinol on Metabolic Acidosis and Endothelial Functions in Chronic Kidney Disease Patients
Secondary ID [1] 284260 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 291379 0
Condition category
Condition code
Renal and Urogenital 291741 291741 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hyperuricemia and metabolic acidosis have emerged as important risk factors for progression of kidney disease. In this study, we aimed to investigate the effects of allopurinol on metabolic acidosis and endothelial functions in hyperuricemic stage 2-4 chronic kidney disease (CKD) patients. Thirty patients with stage 2-4 CKD and serum uric acid levels over 5.5 mg/dL were included in the study group. They were prescribed 300 mg/day per oral allopurinol treatment for three months. In order to monitor adherence to the intervention, we have counted allopurinol tablets in the clinical visits. Age and gender matched CKD patients (n=30) with similar clinical characteristics were taken as the control group and they were not given allopurinol treatment. Endothelial functions were measured via flow mediated dilatation over forearm. pH and HCO3 levels in venous blood, Cr clearance and proteinuria levels from 24 hour urine collection were calculated in all patients at baseline and during the third month.
Intervention code [1] 288965 0
Treatment: Drugs
Comparator / control treatment
The CKD patients who admitted to the Nephrology Outpatient Clinic of Suleyman Demirel University Hospital were searched and patients fulfilling the inclusion criteria were entered into the study. They were separated into two groups in a consecutive manner. Thirty patients with stage 2-4 CKD and serum uric acid levels over 5.5 mg/dL were included in the study group. They were prescribed 300 mg/day per oral allopurinol treatment for 3 months. Age and gender matched CKD patients (n=30) with similar clinical characteristics were taken as the control group and they were not given allopurinol treatment. The dosage of antihypertensive drugs, lipid-lowering agents, and antiplatelet drugs were continued and adjusted according to the each patient’s clinical condition.
Control group
Active

Outcomes
Primary outcome [1] 291677 0
differences in creatinine clearance. Creatinine clearances of the patients were assessed via 24 hour urine collection
Timepoint [1] 291677 0
assessed at three months from baseline
Secondary outcome [1] 307271 0
serum bicarbonate levels. It was acquired from venous blood gas analysis.
Timepoint [1] 307271 0
three months
Secondary outcome [2] 307406 0
Percentage of flow mediated dilation values: Flow mediated vasodilatation (FMD) measurements of the brachial artery were performed by using high-resolution ultrasound with a 12-MHz probe. Assessments were made by a single observer who was blind to the baseline characteristics and laboratory investigations. The subjects remained at rest in the supine position for at least 15 min before the examination started. Two adjacent measurements of end-diastolic brachial artery diameter were performed from single two-dimensional frames. A pneumatic tourniquet was inflated to 200 mm Hg with obliteration of the radial pulse and after five minutes, the cuff was deflated. Flow measurements were made 60 seconds after deflation. The maximum dilatation diameters were calculated as the average of two consecutive maximum diameter measurements. The FMD was then calculated as the percentage change in diameter compared with baseline resting diameters (?FMD percentage). Like all other assessments, ?FMD measurements were also repeated at the third month.
Timepoint [2] 307406 0
three months

Eligibility
Key inclusion criteria
The inclusion criteria were as follows; being a CKD patient at stage 2-4, age between 18 and 80 years old, having serum uric acid levels over 5.5 mg/dl and giving written informed consent to enter this study.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria were: being on renal replacement therapy, hyperuricemia due to malignancy, having peripheral arterial disease, gouty arthritis, a history of allopurinol intolerance, being already on allopurinol treatment, having active infections or inflammatory diseases.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/01/2012
Actual
2/01/2012
Date of last participant enrolment
Anticipated
30/11/2012
Actual
30/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5890 0
Turkey
State/province [1] 5890 0
Isparta

Funding & Sponsors
Funding source category [1] 288882 0
Self funded/Unfunded
Name [1] 288882 0
Country [1] 288882 0
Primary sponsor type
Individual
Name
Dilara Bayram
Address
Suleyman Demirel University, School of Medicine,32260, Cunur, Isparta
Country
Turkey
Secondary sponsor category [1] 287575 0
Individual
Name [1] 287575 0
Salih Inal
Address [1] 287575 0
Suleyman Demirel University, School of Medicine,32260, Cunur, Isparta
Country [1] 287575 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290711 0
Suleyman Demirel University, School of Medicine, Local Ethics Committee
Ethics committee address [1] 290711 0
Ethics committee country [1] 290711 0
Turkey
Date submitted for ethics approval [1] 290711 0
Approval date [1] 290711 0
Ethics approval number [1] 290711 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46918 0
Dr Salih Inal
Address 46918 0
Suleyman Demirel University, School of Medicine, Department of Internal Medicine, Division fo Nephrology

32260, Cunur, Isparta, TURKEY
Country 46918 0
Turkey
Phone 46918 0
+902462119212
Fax 46918 0
Email 46918 0
[email protected]
Contact person for public queries
Name 46919 0
Salih Inal
Address 46919 0
Suleyman Demirel University, School of Medicine, 32260, Cunur, Isparta
Country 46919 0
Turkey
Phone 46919 0
+902462119219
Fax 46919 0
Email 46919 0
[email protected]
Contact person for scientific queries
Name 46920 0
Salih Inal
Address 46920 0
Suleyman Demirel University, School of Medicine, 32260, Cunur, Isparta
Country 46920 0
Turkey
Phone 46920 0
+902462119219
Fax 46920 0
Email 46920 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.