Protocol summary

Summary
This randomized controlled clinical trial study was designed to investigate efficacy of losartan in treatment of post renal transplantation hyperuricemi. After signing informed consent, total 70 kidney transplanted patient with normal and stable renal function enter into our study.Exclusion criteria are: 1- renal artery stenosis 2- episode of acute rejection during last month 3- cardiac and cerebrovascular complications during last month or every abnormal function of heart, lung or liver 4- receiving ARBs, ACEIs or uric acid lowering agents and during study: 5- more than 50% rise in serum creatinine 6- SBP<90mmhg orDBP<60mmhg 7- hemoglobin below 100 g/ L. They are cathegorized into two groups , 35 patients recieving losartan and 35 patients with no drug reception as control. Patients group take 50 mg per day losartan for 6 months. Serum potassium concentration, serum albumin, urea nitrogen level, serum creatinine, serum uric acid, hemoglobin and whole blood CsA through level willbe measured 1,2,3 and 6 months therafter.All the patients willbe on 3 drug protocol including a Calcineurin inhibitor, Steroid, Cellcept or Imuran. Patient's blood pressure and GFR willbe measured frequently.No one takes ACEIs, ARBs or uric acid lowering agents before enterance into the study. Indications for prescription of losartan are: hyperuricemia (uric acid>7mg/dl) and abscence of above contraindications.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111108032N1
Registration date: 2012-09-22, 1391/07/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-09-22, 1391/07/01
Registrant information
Name
Sima Abediazar
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 7054
Email address
abediazars@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Sima Abediazar
Expected recruitment start date
2012-02-04, 1390/11/15
Expected recruitment end date
2012-04-03, 1391/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy Of Losartan In Treatment Of Hyperuricemia After Renal Transplantation
Public title
Efficacy Of Losartan In Treatment Of Hyperuricemia After Renal Transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Post renal transplant patients; Normal and stable renal function; Completion of testimonial Exclusion criteria: Transplanted renal artery stenosis; Acute rejection episode during last month; cardiovascular or cerebrovascular complications during last month or any abnormality in cardiac, lung or liver function; taking ACEIs , ARBs or any uric acid lowering agent and during study; more than 50% rise in serum creatinine; systolic blood pressure less than 90mmHg or diastolic blood pressure less than 60mmHg; Hb less than 100gr/L
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
N/A
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
Ethics Committee Of Tabriz University Of Medical Science
Street address
Tabriz University Of Medical Science, Golgasht Ave.
City
Tabriz
Postal code
5165665931
Approval date
2012-08-01, 1391/05/11
Ethics committee reference number
9172

Health conditions studied

1

Description of health condition studied
Compliations Of Kidney Trasplantation
ICD-10 code
Z94.0
ICD-10 code description
Kidney Transplant Status

Primary outcomes

1

Description
serum uric acid level
Timepoint
before taking Losartan,1st,2d,3rd &6th month
Method of measurement
laboratory

Secondary outcomes

1

Description
serum potassium concentration
Timepoint
before taking Losartan,1st,2d,3rd &6th month
Method of measurement
laboratory

2

Description
serum creatinine level
Timepoint
before taking Losartan,1st,2d,3rd &6th month
Method of measurement
laboratory

3

Description
urea nitrogen level
Timepoint
before taking Losartan,1st,2d,3rd &6th month
Method of measurement
laboratory

4

Description
hemoglobin
Timepoint
before taking Losartan,1st,2d,3rd &6th month
Method of measurement
laboratory

5

Description
whole-blood CSA through level.
Timepoint
before taking Losartan,1st,2d,3rd &6th month
Method of measurement
laboratory

6

Description
serum albumin
Timepoint
before taking Losartan,1st,2d,3rd &6th month
Method of measurement
laboratory

Intervention groups

1

Description
Intervention group: 50mg per day, Losartan for 6 months
Category
Treatment - Drugs

2

Description
Control group: no drug
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic Of Nephrology, Imam Reza Hospital
Full name of responsible person
Sima Abediazar
Street address
Imam Reza Hospital, Golgasht Ave.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Assistance Of Tabriz University Of Medical Science
Full name of responsible person
Mohammad Reza Rashidi
Street address
Research Assistance, Tabriz University Of Medical Science, Golgasht Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistance Of Tabriz University Of Medical Science
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
Tabriz University Of Medical Science
Full name of responsible person
Sima Abediazar
Position
Nephrologist/Associate Professor
Other areas of specialty/work
Street address
Office Of Internal Medicine Group, Imam Reza Hospital, Golgasht Ave.
City
Tabriz
Postal code
5166614756
Phone
+98 41 1334 7054
Fax
Email
abediazars@tbzmed.ac.ir, nasseri.f10@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University Of Medical Science
Full name of responsible person
Sima Abediazar
Position
Nephrologist/Associate Professor
Other areas of specialty/work
Street address
Office Of Internal Medicine Group, Imam Reza Hospital, Golgasht Ave.
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
abediazars@tbzmed.ac.ir, nasseri.f10@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University Of Medical Science
Full name of responsible person
Faranak Nasseri
Position
Internal Medicine Assistant
Other areas of specialty/work
Street address
Office Of Internal Medicine Group, Imam Reza Hospital, Golgasht Ave.
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
+98 41 1336 4659
Email
nasseri.f10@gmail.com, abediazars@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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