The aim of this study was to evaluate the effect of allopurinol on the improvement of metabolic acidosis in chronic renal failure. This study was conducted on patients with renal insufficiency, stage 2 to 4. The sample contains 50 people who are randomly selected in to two groups of 25 people. In the treatment group, allopurinol 100 mg daily was given to the patients and the control group received placebo. Then patients' metabolic acidosis and bicarbonate level will be measured at the start of study and after 3 months. This study was performed in two centers.
Inclusion criteria:age 18-80, Chronic kidney disease stage 2-4, both genders.
Exclusion criteria: gout, myeloprolifrative disorder, allopurinol user, allergy to allopurinol, uric acid>10, active infection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122731604N1
Registration date:2017-08-05, 1396/05/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-05, 1396/05/14
Registrant information
Name
Maryam Miri
Name of organization / entity
Mashhad University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 3781
Email address
mirighm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancoller for research Mashhad University Of Medical Siences
Expected recruitment start date
2017-04-30, 1396/02/10
Expected recruitment end date
2017-11-01, 1396/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial of Assessing Allopurinol Effect on Metabolic Acidosis in Patients with Chronic renal failure stage 2-4
Public title
Assessing Allopurinol Effect on Metabolic Acidosis in Patients with Chronic renal failure stage 2-4
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion:age 18-80,Chronic kidney disease stage 2-4,both gender
exclusion:gout,myeloprolifrative disorder,allopurinol user ,allergy to allopurinol, uric acid>10,active infection
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomised with closed envelopes
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee Of Mashhad University of Medical Siences
Street address
Daneshgah street
City
Mashhad
Postal code
Approval date
2016-04-26, 1395/02/07
Ethics committee reference number
IR.MUMS.REC.1395.247
Health conditions studied
1
Description of health condition studied
CKD
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
2
Description of health condition studied
CKD stage 2-4
ICD-10 code
N18.2-N18.
ICD-10 code description
Kidney damage with mild decreased GFR (60-89 mL/min
Primary outcomes
1
Description
bicarbonate
Timepoint
before intervention,after 3 month
Method of measurement
blood level meq/L
2
Description
uric acid
Timepoint
before intervention,3 month
Method of measurement
blood level mg/mL
Secondary outcomes
empty
Intervention groups
1
Description
allopurinol 1 tablet of Allopurinol 100mg per day in intervention group for 3 mounth
Category
Treatment - Drugs
2
Description
placebo in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Maryam Miri Ghalehnovi
Street address
Ahmadabad Street
City
Mashhad
2
Recruitment center
Name of recruitment center
Montaserie hospital
Full name of responsible person
Maryam Miri Ghalehnovi
Street address
Golestan Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University Of Medical Siences
Full name of responsible person
Vice chancoller for research Mashhad University Of Medical Siences
Street address
Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University Of Medical Siences
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
Mashhad University of Medical Siences
Full name of responsible person
Maryam Miri Ghalehnovi
Position
Nephrologist
Other areas of specialty/work
Street address
Internal Ward,Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 3840 0000
Fax
Email
mirighm@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Siences,school of medicine
Full name of responsible person
Maryam Miri Ghalehnovi
Position
Nephrologist
Other areas of specialty/work
Street address
Internal Ward ,Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 3840 0000
Fax
Email
mirighm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Siences
Full name of responsible person
Maryam Miri Ghalehnovi
Position
Assistant professor of nephrology
Other areas of specialty/work
Street address
Internal Ward,Ghaem Hospital
City
Mashhad
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)