This study will be done with aim to determine the effects of allopurinol in renal disease progress. This study is a double blind clinical trial. The study population includes patients with chronic renal insufficiency are referred to Mahdieh clinic in Kermanshah city,that 180 patients purposefully selected and randomly will divided into two (each group, n = 90) control and exprimental groups. In the experimental group allopurinol 100 mg will be given under the supervision of nephrologist ,daily for 12 months. The control group daily will receive 100 mg of placebo,daily for 12 months. Then in both groups at beginning of the study, and at 3,6 and 12 months the kidney function of patients with GFR, uric acid and creatinine is assessed.
Inclusion criteria: informed consent of the patient;the diagnosis of renal glomerular filtration ;(GFR) of less than 60 and over 15; uric acid greater than 6 mg per dL; age over 18 years; no history of hospitalization during the past three months due to renal disease and no increase in creatinine number greater than 50% compared to the 3months ago.
Exclusion criteria: allopurinol intolerance;allergy; the possibility of pregnancy; liver disease history of gout.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101714333N43
Registration date:2015-10-30, 1394/08/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-30, 1394/08/08
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2014-10-17, 1393/07/25
Expected recruitment end date
2015-10-17, 1394/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Allopurinol on progression of renal disease
Public title
Effect of Allopurinol on Chronic Kidney Disease Progression.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: informed consent of the patient;the diagnosis of renal glomerular filtration ;(GFR) of less than 60 and over 15; uric acid greater than 6 mg per dL; age over 18 years; no history of hospitalization during the past three months due to renal disease and no increase in creatinine number greater than 50% compared to the 3months ago.
Exclusion criteria: allopurinol intolerance;allergy; the possibility of pregnancy; liver disease history of gout
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2014-10-14, 1393/07/22
Ethics committee reference number
31220/پ/7/420
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
N18
ICD-10 code description
Chronic renal failure
Primary outcomes
1
Description
GFR level
Timepoint
At beginning of the study, and at 3,6 and 12 months after study
Method of measurement
Using the formula Modification of Diet in Renal Disease(MDRD)
2
Description
Using the formula creatinine
Timepoint
At beginning of the study, and at 3,6 and 12 months after study
Method of measurement
Based on blood tests
3
Description
uric acid
Timepoint
At beginning of the study, and at 3,6 and 12 months after study
Method of measurement
Based on blood tests
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group allopurinol 100 mg will be given under the supervision of nephrologist ,daily for 12 months. Then at beginning of the study, and at 3,6 and 12 months the kidney function of patients with GFR, uric acid and creatinine is assessed.
Category
Treatment - Drugs
2
Description
In the control group will receive 100 mg of placebo daily for 12 months. Then at beginning of the study, and at 3,6 and 12 months the kidney function of patients with GFR, uric acid and creatinine is assessed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Mahdieh
Full name of responsible person
Mehrnoosh Manoochehri
Street address
Clinic of Mahdieh, Crossroads Javanshir
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Sima Golmohammadi
Position
Nephrologist
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6309
Fax
Email
simag_2000@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)