This study was a randomized clinical trial that was done with the aim of determination of the effect of erythropoietin on glomerular filtration rate in patients with chronic kidney disease with mild anemia in diabetic nephropathy, on 60 patients with CKD stage II. Inclusion criterion was having CKD stage II and exclusion criterion was having anemia due to another cause except CKD. After inclusion in the study, the patients were randomly divided into two equal groups, erythropoietin receivers and control group. Erythropoietin receivers were given erythropoietin 25 U/Kg every other day so as to maintain hemoglobin level at 13 g/dl in men and at 12 in women, but the control group didn’t receive any drug, and at the end of the study the results of the two groups were compared together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016043027686N1
Registration date:2016-06-04, 1395/03/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-04, 1395/03/15
Registrant information
Name
Maryam Khalili Sadr
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3235 3222
Email address
m.khalili@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2015-01-10, 1393/10/20
Expected recruitment end date
2016-01-10, 1394/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of erythropoietin on glomerular filtration rate in patients with chronic kidney disease with mild anemia in diabetic nephropathy
Public title
Erythropoeitin effect on Chronic Kidney Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with stage II CKD
Exclusion criteria: Anemia due to another disease except CKD; History of secondary hyperthyroidism; Malignancies
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Approval date
2014-11-30, 1393/09/09
Ethics committee reference number
ir.zaums.rec.1393.6934
Health conditions studied
1
Description of health condition studied
Chronic Kidney Disease
ICD-10 code
N18.2
ICD-10 code description
Kidney damage with mild decreased GFR (60-89 mL/min)
Primary outcomes
1
Description
Glomerular Filtration Rate
Timepoint
Before intervention, after intervention with 2 months intervals till 6 months
Method of measurement
Using Formula
Secondary outcomes
empty
Intervention groups
1
Description
Treatment group: Erythropoeitin 25U/Kg every other day
Category
Treatment - Drugs
2
Description
Control group: no drugs
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebne Abi Taleb Hospital
Full name of responsible person
Maryam Khalili Sadr
Street address
Khalije Fars Blv, Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hoshang Rafighdoost
Street address
Deputy of research and technology, Zahedan University of Medical Sciences campus, Jannat Blv, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Khalili Sadrabad
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
No.17, Masjed Jame street, Emam street, Meibod, Yazd
City
Yazd
Postal code
Phone
+98 35 3235 3222
Fax
Email
m.khalili@zaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Alidadi
Position
Associate Professor
Other areas of specialty/work
Street address
Ali ebne Abi Taleb Hospital, Khalije Fars Blv, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5715
Fax
Email
dralidadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ali ebne Abi Taleb Hospital
Full name of responsible person
Maryam Khalili Sadr
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
No.17, Masjed Jame street, Emam street, Meibod, Yazd
City
Yazd
Postal code
Phone
+98 35 3235 3222
Fax
Email
m.khalili@zaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)