| CTRI Number |
CTRI/2024/10/074915 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluating the glycaemic profile of renal transplant patients on short acting tacrolimus and long acting tacrolimus |
|
Scientific Title of Study
|
Post-Transplant Glycaemic Changes in the Renal Allograft Recipient with Prolonged Release Tacrolimus compared to the Immediate Release: A Randomised Controlled Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smita Pattanaik |
| Designation |
Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Room no 4015
Level 4
Research Block B
Department of Pharmacology
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9497518529 |
| Fax |
|
| Email |
dr.smita.lab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwin Kumar A |
| Designation |
Junior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Room no 4030
Level 4
Research Block B
Department of Pharmacology
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9497518529 |
| Fax |
|
| Email |
ashwinkumar315@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita Pattanaik |
| Designation |
Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Room no 4015
Level 4
Research Block B
Department of Pharmacology
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9497518529 |
| Fax |
|
| Email |
dr.smita.lab@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pharmacology Department Thesis Grant,
Department Of Pharmacology
Level 4
Research Block B
PGIMER Chandigarh
pin: 160012 |
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
PGIMER
Sector 12
Chandigarh
PIN: 160015 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smita Pattanaik |
PGIMER Chandigarh |
Room no 4030
Level 4
Department of Pharmacology
Sector 12
Chandigarh
PIN: 160012
Chandigarh
CHANDIGARH |
9497518529
dr.smita.lab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Immediate Release Tacrolimus |
Short Acting Formulation of Tacrolimus for 45 days post transplantation |
| Intervention |
Prolonged Release Tacrolimus |
Long acting formulation of Tacrolimus for 45 days post transplantation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
. Patients of age 18-55 years who are undergoing renal transplant.
2. Participants willing to provide written informed consent.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. All subjects must agree not to share medication.
5. Subject (male or female) is willing to use highly effective methods during the study treatment (adequate: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence).
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of participants with deranged Oral Glucose Tolerance Test (OGTT) after 45 days of transplantation between Prolonged release versus Immediate release tacrolimus group. |
The proportion of participants with deranged Oral Glucose Tolerance Test (OGTT) at baseline and after 6 weeks of transplantation between Prolonged release versus Immediate release tacrolimus group. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
 To compare the exposure to tacrolimus in one dosing interval (AUC 0-24) and (AUC 0-12) at one-month post-transplantation in the Prolonged release tacrolimus versus Immediate release group respectively.
 To compare the change in fasting plasma lipids and biomarkers (Fasting insulin, OGTT insulin, C-peptide, proinsulin, proinsulin/C-peptide, proinsulin/insulin ratio) pre-transplant period to the post-transplant period (45 days).
 To compare the acute rejection rate, and graft outcome (eGFR & urinary albumin) between Prolonged release tacrolimus versus immediate release tacrolimus group.
 Retrospective analysis of the genotype and its influence in metabolism.
|
30 days post transplant
3 months post transplant
6 months post transplant |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To understand the changes in the glucose and lipid metabolism, graft function(eGFR), markers of beta cell damage and insulin resistance in a kidney transplant recipient with Prolonged Release tacrolimus compared to the Immediate Release tacrolimus. We hypothesize that the incidence of PTDM will be reduced by at least 50% (30% to 15%) in a non-genotype stratified population by using a Tac-PR formulation compared to the Tac-IR formulation. Further, we believe that the effect will be more pronounced in recipients with pre-existing risk for PTDM in the pre-transplant period, and our study may be able to elucidate the biomarkers for early detection of PTDM. Study will be conducted in the Renal Transplant Ward and ICU, Nehru hospital, PGIMER, Chandigarh. The potential patients/legal attendant will be approached and asked for their voluntariness to participate in the study. The study details will then be described in their vernacular language and patient information sheet will be filled. A written informed consent will be taken from all the participants. The patients will be screened for eligibility as per inclusion/exclusion criteria. The pretransplant biomarker evaluations will include OGTT test (for glucose, insulin, C-peptide, and proinsulin) and fasting lipid profile; these will be repeated 45 days after the surgery. The patients will be randomized to receive Tac-IR or Tac-PR formulations in 1:1 ratio. The starting dose of the drug for the Tac-IR will be 0.1- 0.2mg/kg/day, 24 to 48 hours prior to transplantation. The same dose of the drug will be started for the Tac-PR group with the required titration for the target C0 concentration window of 10-15ng/ml for the first 30 days and 8-10ng/ml thereafter. Dose titration will be performed every three days until the target window is reached. The patients will be advised to perform the C0 twice a week in the first 4 week and weekly thereafter.
The recruited participants in the primary study would be invited to participate in the pharmacokinetic study which involves multiple blood sample collection over a 12-hour/24-hour period. They will be housed in the Clinical Pharmacology Unit of the Department of Pharmacology. 2ml blood samples will be obtained in EDTA vial before the routine drug administration for the patient. The drug will be administered in a supervised manner, and 2 ml of blood sample will be obtained in EDTA vials over a single dosing interval at 0.5, 1.5, 2, 4,8,12 and 24 hours. All the samples will be stored at 4C, and the quantification for whole blood tacrolimus will be performed within seven days of collection by LCMS/MS method (AB Sciex 3500) in the Department of Pharmacology.
|