Protocol summary

Summary
The aim of this study is to determine the anti-inflammatory effects of azithromycin in the grafted kidney function. Inclusion criteria are: all selected patients for nephrectomy (live or cadaver). Exclusion criteria included drug abuse; history of susceptibility to azithromycin; severe cardiovascular disorders. In this double blind study patients randomly will be divided into two groups (Random permutation block sampling). 1- Azithromycin group: one gram azithromycin will be administered 24 hours before the operation to live or cadaver kidney donor. 2- Placebo group: The patients of this group will be given 1 gram of placebo, 24 hours before the operation. Patients will follow-up 12 weeks. Possible side effects in patients will be recorded. The examination will be carried out at intervals of days before the operation, 24, 48 and 96 hours after surgery in donors and recipients and also 30 days and 90 days after transplantation in recipients. Initial outcome will be kidney function (measured by GFR), secondary outcome will be donor's pain and third outcome will be laboratory inflammatory markers in the donor and recipients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201606141853N11
Registration date: 2016-09-05, 1395/06/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-05, 1395/06/15
Registrant information
Name
Siavash Falahatkar
Name of organization / entity
Urology Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 3352 5259
Email address
urc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Urology Research Center, Guilan University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Assessment of Anti-inflammatory effect of Azithromycin on kidney donor and potential effect on recipient
Public title
Assessment of Anti-inflammatory effect of Azithromycin on kidney donor and potential effect on recipient
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Alive or cadaveric donor; Sign the inform consent by donor or Family of cadaver Exclusion criteria: Allergic components or allergic to various brands of Azithromycin; Severe medical disease like heart, liver, renal, hematological; respiratory, cardiovascular, psychiatric or other problem pre transplantation in donor; Consumption of other medication including Macrolides family; Involvement in additional clinical trials at the same time
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients in this study will be randomized by Random Permutation Block.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Opposite Sepah Bank, Western Shahid Beheshti Blvd., Gaz Square
City
Rasht
Postal code
41938-93345
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
IR.GUMS.REC.1395.105

Health conditions studied

1

Description of health condition studied
Transplanted kidney function
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
GFR
Timepoint
1 day, 2 days, 4 days, 30 days and 90 days after transplantation
Method of measurement
Cockcroft-Gault Equation

Secondary outcomes

1

Description
Complication
Timepoint
1 day, 2 days, 4 days, 30 days and 90 days after transplantation
Method of measurement
Registration of physical examination, medical history and paraclinical findings

2

Description
Pain score in donors
Timepoint
1 day, 2 days and 4 days after transplantation
Method of measurement
Visual Analog Scale (VAS)

Intervention groups

1

Description
Intervention group: Capsule of Azithromycin 1 g, 24 hours before nephrectomy, Made in Iran
Category
Treatment - Drugs

2

Description
Control group: Capsule of placebo 1 g, 24 hours before nephrectomy, Made in Iran
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Mojtaba Teimoori (Resident)
Street address
Sardar Jangal Street, Razi hospital
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urology Research Centre, Guilan University of Medical Sciences
Full name of responsible person
Dr. Siavsh Falahatkar
Street address
Sardar Jangal Street, Razi hospital, Urology Research Centre
City
Rasht
Grant name
Grant code / Reference number
32
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Centre, Guilan 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
Urology Research Center
Full name of responsible person
Dr. Mojtaba Teimoori
Position
Co worker/Resident
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
urc1384@yahoo.com;mojtaba_teimoori@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Gholamreza Mokhtari
Position
Associated Proffesor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
gh.mokhtari@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Samaneh Esmaeili
Position
Research Expert/Master
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
4144895655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
urc1384@yahoo.com
Web page address

Sharing plan

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