| CTRI Number |
CTRI/2024/12/077757 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Proof of Concept |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Analysis of Mycophenolic Acid in saliva matrix in Renal Transplant patients |
|
Scientific Title of Study
|
Investigating the Feasibility of Estimating Mycophenolic Acid from Saliva using
High Performance Liquid Chromatography – Fluorescence Method for Determining
Mycophenolate Exposure in Patients with Renal Transplantation
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Smita Pattanaik |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Room no. 4015, Department of Pharmacology, Research block B, PGIMER,Chandigarh
Lab no 4030, 4th floor, Department of Pharmacology, Research Block B, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872269171 |
| Fax |
|
| Email |
dr.smita.lab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BAHAAR MANRO |
| Designation |
Student |
| Affiliation |
PGIMER |
| Address |
Lab no 4030, 4th floor, Department of Pharmacology, Research Block B, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872269171 |
| Fax |
|
| Email |
bahaar279@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Smita Pattanaik |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Room no. 4015, Department of Pharmacology, Research block B, PGIMER,Chandigarh
Lab no 4030, 4th floor, Department of Pharmacology, Research Block B, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872269171 |
| Fax |
|
| Email |
dr.smita.lab@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Chandigarh, India
pin code- 160012 |
|
|
Primary Sponsor
|
| Name |
Department of Pharmacology |
| Address |
Department of Pharmacology, Research Block B, PGIMER, Chandigarh, India
pin code - 160012 |
| 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 |
LABA 4030, 4TH FLOOR, DEPARTMENT OF PHARMACOLOGY, RESEARCH BLOCK B, PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH |
9872269171
dr.smita.lab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PGIMER |
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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult stable renal transplantation studies and patients with normal albumin range. |
|
| ExclusionCriteria |
| Details |
Patients with multi organ transplantation
Pregnant or lactating women
Patients with secondary infection or malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anticipated outcomes involve confirming the specificity and selectivity of the established High Performance Liquid Chromatography- fluorescence method for determining Mycophenolic Acid (MPA) concentrations in both saliva and plasma. The success of this method could position it as a reliable approach for Therapeutic Drug Monitoring (TDM) of MPA in diverse patient groups, irrespective of age. |
Before drug administration, 20 mins after drug administration followed at 1hr, 2hr, 4 hr , 6 hr , 8 hr and 12 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| correlation between plasma AUC and saliva AUC of MPA in Renal transplant patients |
Before drug administration, 20 mins after drug administration followed at 1hr, 2hr, 4 hr , 6 hr , 8 hr and 12 hr |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/12/2024 |
| 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="2"
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
|
We believe that our study will be able to validate a non-invasive method of Therapeutic Drug Monitoring for Mycophenolate Mofetil (MMF) using saliva samples and in developing an algorithm correlating salivary concentrations of MMF to that of blood concentrations of MMF. The study will be conducted in the Department of Pharmacology, PGIMER in collaboration with Department of Renal Transplantation and Surgery, PGIMER. The study will include 30 adult patients who have undergone renal transplantation ≥4 weeks prior and are prescribed MMF twice daily and have maintained a stable dosage for the past two weeks. Those willing to participate, and provide consent will be screened for inclusion in the study. Blood and saliva specimen will be collected prior to the administration of MMF, with subsequent samples obtained at specified intervals of 0.33, 1, 2, 4, 6, 8, and 12 hours following MMF administration. The samples will be further analyzed using High Performance Liquid Chromatography using Fluorescence detector. The exposure of Mycophenolic Acid (MPA) will be calculated using AUC (0-12 hour) and correlation between saliva and plasma MPA will be established using parametric or non-parametric statistical tests. |