Evaluation of the effect of conversion to extended-release tacrolimus on intrapatient variability of trough level
Design
A singe armed,open Label,non-randomized clinical trial in 100 kidney transplant patients who had IPV on immediate release Tacrolimus
Settings and conduct
A open labeled singla-arm non-randomized clinical trial in kidney transplant patients 1 with Coefficient variation of tacrolimus trough level > 15% will be enrolled in Labbafinejad medical center and their medication will be converted from immediate release to extended release tacrolimus on 1:1 conversion ratio.Coefficient variation of tacrolimus trough level will be calculated during 3 months after conversion.
Participants/Inclusion and exclusion criteria
Kidney transplant patients with coefficient variation of tacrolimus level >15% will be enrolled.
Those with history of rejection or non compliance will be excluded
Intervention groups
Transplant patients undergo conversion from immediate release to extended release Tacrolimus
Main outcome variables
Evaluation of coefficient variation of drug level 3 months after conversion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211221053480N1
Registration date:2022-04-10, 1401/01/21
Registration timing:registered_while_recruiting
Last update:2022-04-10, 1401/01/21
Update count:0
Registration date
2022-04-10, 1401/01/21
Registrant information
Name
Shiva Samavat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2360 2188
Email address
samavat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of Once-daily Extended Release Tacrolimus on Intrapatient Variability of Trough Level in Kidney Transplant Recipients
Public title
Extended Release Tacrolimus on Intrapatient Variability in Kidney Transplant Recipients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Kidney transplantation alone
At least 6 months post transplantation
Stable graft function
Stable Tacrolimus dosage
Coefficient variation of drug level >30%
On tacrolimus twice daily
Tacrolimus+MPA+prednisolone regime
Exclusion criteria:
History of acute rejection within 3 months
Active infection
Not willing to participate
Participating in other trials
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Before- After study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Urology and Nephrology Research Center- Shahid Beheshti University of
Street address
Ministry of health and medical education.South Falamak st. Theran
City
tehran
Province
Tehran
Postal code
141994371
Approval date
2022-01-22, 1400/11/02
Ethics committee reference number
IR.SBMU.UNRC.REC.1400.021
Health conditions studied
1
Description of health condition studied
Kidney transplantation
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status
Primary outcomes
1
Description
Coefficient variation of drug level
Timepoint
3 months after conversion
Method of measurement
Drug level measurement with HPLC technique monthly and calculating coefficient variation
Secondary outcomes
1
Description
graft function
Timepoint
3 months after conversion
Method of measurement
GFR with creatinine based formula (CKD-EPI)
Intervention groups
1
Description
Intervention group:In selected patients, convert Prograf®- Astellas to Advagraf®- Astellas : A 1:1 conversion from immediate-release tacrolimus to extended-release tacrolimus capsules and treatment will be continued for at least 3 months.Tacrolimus should be monitored using 24-hour trough (C0) concentrations for the extended-release preparations: in 3 days and monthly for 3 months and coefficient variation will be calculated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad medical center
Full name of responsible person
Shiva Samavat
Street address
9th Boostan st. Pasadarn Ave.
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2258 0333
Email
shsamavat@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohsen Nafar
Street address
9th Boostan st. Pasadarn Ave.
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2258 0333
Email
m.nafar.md@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Behestan Darou
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shiva Samavat
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
9th Boostan st. Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2258 0333
Email
shsamavat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shiva Samavat
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
9 th Boostan st. Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2258 0333
Email
shsamavat@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shiva Samavat
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
9th Boostan st. Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2258 0333
Email
shsamavat@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available