This study is designed to evaluate the effect of metformin on the cyst and kidney volumes in patients with autosomal dominant poly-cystic kidney disease. During this study the patients will recieve Metformin tablet 500mg (Rojin Daroo Comapny) once daily for one week and two tablets daily for second week and three tablets daily thereafter for 6 months. Serum creatinine level, glomerular filtration rate, 24-hour urinary protein, serum C-reactive protein (CRP) and interleukin 6 (IL-6), and kidney and cyst volumes using magnetic resonance imaging (MRI) will be assesed at the begining and at the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013021912527N1
Registration date:2014-10-25, 1393/08/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-25, 1393/08/03
Registrant information
Name
Farrokhlegha Ahmadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1568
Email address
ahmadifa@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2014-02-22, 1392/12/03
Expected recruitment end date
2014-10-30, 1393/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of metformin on cyst volume and kidney volume in patients with Autosomal dominant polycystic kidney disease (ADPKD)
Public title
Effect of metformin on the volume of cysts and kidneys in poly-cystic kidney disease patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Serum creatinine less than 1.4mg/dL at the beginning of the study; signing the informed consent form
Exclusion criteria:
previous history of metformin use; allergy to metformin; any side effect during the intervention which prevents the patient from continuing the study
Age
From 14 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods-Keshavarz cross, Keshavarz Boulvard
City
Tehran
Postal code
Approval date
2014-02-22, 1392/12/03
Ethics committee reference number
19490
Health conditions studied
1
Description of health condition studied
Polycystic kidney disease
ICD-10 code
Q61.2
ICD-10 code description
Polycystic Kidney, autosomal dominant; Polycystic kidney adult type
Primary outcomes
1
Description
Volume of cyst
Timepoint
Before and after intervention
Method of measurement
MRI
2
Description
Kidney volume
Timepoint
Before and after intervention
Method of measurement
MRI
Secondary outcomes
1
Description
Serum creatinine
Timepoint
Before and after intervention
Method of measurement
Jaffe method
2
Description
24h-Urine protein
Timepoint
Before and after intervention
Method of measurement
Laboratory
3
Description
Serum IL-6
Timepoint
Before and after intervention
Method of measurement
kit
4
Description
Serum CRP
Timepoint
Before and after intervention
Method of measurement
Kit
5
Description
GFR
Timepoint
Before and after intervention
Method of measurement
Calculation
Intervention groups
1
Description
Patients will take 1 tablet of metformin 500 mg (Rogin Daroo Company) daily for the first week, two tablets daily for the second week and three tablets daily thereafter up to six months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Farrokhlegha Ahmadi
Street address
Gharib Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Keshavarz Boulevard
City
Tehran
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, Tehran 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
Name of organization / entity
Nephrology Resaerch Center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Farrokhlagha Ahmadi
Position
Nephrologist, Associate Proffessor
Other areas of specialty/work
Street address
Dialysis ward, Imam Khomeini Hospital, Gharib Street
City
Tehran
Postal code
Phone
+98 21 6658 1568
Fax
Email
ahmadifa@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nephrology Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Farrokhlagha Ahmadi
Position
Nephrologist, Associate Professor
Other areas of specialty/work
Street address
Dialysis ward, Imam Khomeini Hospital, Gharib Street
City
Tehran
Postal code
Phone
+98 21 6658 1568
Fax
Email
ahmadifa@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nephrology Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Farrokhlegha Ahmadi
Position
Nephrologist, Associate Professor
Other areas of specialty/work
Street address
Dialysis ward, Imam Khomeini Hospital, Gharib Street
City
Tehran
Postal code
Phone
+98 21 6658 1568
Fax
Email
ahmadifa@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)