The determination of the effect of allopurinol on nephropathy in diabetic patients
Design
Clinical trial with control group, parallel group, double blind, randomized
Settings and conduct
Sixty diabetic nephropathy patients with hyperuricemia referred to Nephrology Clinics of Shahrekord University of Medical Sciences were selected by convenience sampling method and randomly divided into control and control groups. The patients were then measured on the first day of 24-hour urine tests for protein, GFR estimates, and serum uric acid levels, and then assigned to one group of allopurinol patients and another to placebo. The patients were followed for 6 months. After 24-hour urine collection follow-up, the protein was measured, GFR estimates and serum uric acid levels were compared, and the results were compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 24-hour urine protein greater than 150mg / dl; Uric acid between 6 and 15; Informed patient satisfaction; The severity of diabetic nephropathy is similar in both groups; Passive urine sedimentation; Exclusion criteria: Patients treated with allopurinol; Patients with significant renal failure (Cr> 3 mg / dl) or (GFR <25cc / min)
Intervention groups
We have two case and control groups. One group of patients was given allopurinol and the other group was given placebo
Evaluation of the effect of allopurinol on nephropathy in diabetic patients
Public title
Effect of allopurinol on diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
24-hour urine protein greater than 150mg / dl
Uric acid between 6 and 15
Informed patient satisfaction
The severity of diabetic nephropathy is similar in both groups
Passive urine sedimentation
Exclusion criteria:
Patients treated with allopurinol
Patients with significant renal failure (Cr> 3 mg / dl) or (GFR <25cc / min)
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
60 diabetic nephropathy patients who were eligible for inclusion in the study will be enrolled by the simple randomized method. Then they will be divided into two groups of 30 using the random block method with 3 blocks. Thus, the first three cases in the first group, the second three cases in the second group, the third three cases in the first group, the forth three cases in the second group and this will be continued in the same way till the ending of samples.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs were placed in envelopes in packages A and B without labeling and without the knowledge of the investigator.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713492
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.SKUMS.REC.1397.303
Health conditions studied
1
Description of health condition studied
Diabetic nephropathy
ICD-10 code
E09.21
ICD-10 code description
Drug or chemical induced diabetes mellitus with diabetic nephropathy
Primary outcomes
1
Description
Serum uric acid level
Timepoint
After 3 and 6 months after starting the study
Method of measurement
Test
2
Description
GFR (Glomerular filtration rate)
Timepoint
After 3 and 6 months after starting the study
Method of measurement
Formula
3
Description
24-hour urine protein content
Timepoint
After 3 and 6 months after starting the study
Method of measurement
24-hour urine test
4
Description
Serum creatinine level
Timepoint
After 3 and 6 months after starting the study
Method of measurement
Test
5
Description
Serum urea level
Timepoint
After 3 and 6 months after starting the study
Method of measurement
Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the case group are treated with allopurinol 100 mg daily
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group receive one placebo daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Clinic
Full name of responsible person
Saeed Mardani
Street address
Shariati Blvd., Imam Ali Clinic
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816788640
Phone
+98 38 3224 2696
Email
drsmardani@yahoo.com
2
Recruitment center
Name of recruitment center
Hazrat Rasool Clinic
Full name of responsible person
Saeed Mardani
Street address
Molavi Street, Hazrat Rasoul Clinic
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816788640
Phone
+98 38 3226 4833
Email
drsmardani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Mehraban Sadeghi
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Saeed Mardani
Position
Assistant Professor of Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Nursery Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3222 0016
Email
drsmardani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Saeed Mardani
Position
Assistant Professor of Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Nursery Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3222 0016
Email
drsmardani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Saeed Mardani
Position
Assistant Professor of Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Nursery Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3222 0016
Email
drsmardani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Imam Ali clinic and Hazrat Rasool clinic
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.