| CTRI Number |
CTRI/2025/10/095801 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Piperine as a Pharmacokinetic Enhancer of Tacrolimus and Mycophenolic Acid in Renal Transplantation |
|
Scientific Title of Study
|
Pharmacokinetic Interaction of Piperine with Tacrolimus and Mycophenolic Acid in the Renal Transplant Recipients. |
| Trial Acronym |
TRANSPIRE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Smita Pattanaik |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research Chandigarh |
| Address |
4015 Level 4
Department of Pharmacology
Post Graduate Institute of Medical Education and Research
Madhya Marg Sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9417724464 |
| Fax |
|
| Email |
pattanaik.smita2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smita Pattanaik |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research Chandigarh |
| Address |
4015 Level 4
Department of Pharmacology
Post Graduate Institute of Medical Education and Research
Madhya Marg Sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9417724464 |
| Fax |
|
| Email |
pattanaik.smita2018@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yazhini R |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate Institute of Medical Education & Research |
| Address |
4030 Level 4
Department of Pharmacology
Post Graduate Institute of Medical Education and Research
Madhya Marg Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9944079162 |
| Fax |
|
| Email |
yazhinirajen14@gmail.com |
|
|
Source of Monetary or Material Support
|
| PostGraduate Institute of Medical Education and Research, Chandigarh and Department of Health Research, Ministry of Health and Family Welfare, Government of India |
|
|
Primary Sponsor
|
| Name |
Department of Health Research |
| Address |
This study will be conducted as a DM dissertation for the partial fulfilment of the said degree |
| Type of Sponsor |
Government funding agency |
|
|
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 |
Department of Renal Transplant Surgery and Department of Pharmacology |
Room No 4015
Department of Pharmacology
P N Chhuttani Block
PostGraduate Institute of Medical Education and Research
Madhya Marg
Sector 12
Chandigarh
Chandigarh
CHANDIGARH |
9417724464
pattanaik.smita2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee PGIMER Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N185||Chronic kidney disease, stage 5, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Piperine |
Tacrolimus + MMF + Piperine 20 mg OD or BD |
| Comparator Agent |
Tacrolimus + MMF |
The participant will be his own control, Tacrolimus and MMF is the standard of care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult renal transplant patients after 1 week post transplantation period aged 18 to 65 years
Those requiring more than 0.3 mg per kgs of tacrolimus
Unable to attain therapeutic tacrolimus trough concentration in the post transplantation period
Renal allograft function returned to CKD 1 or 2
Hepatic function within normal limits
Hb more than 10
Willing to comply with the study procedures by providing written informed consent |
|
| ExclusionCriteria |
| Details |
Recipients of multi-organ transplantation
Concurrent use of drugs altering tacrolimus pharmacokinetics other than prednisolone
Patients have been started on ketoconazole or diltiazem due to non-attainment of desired trough concentration
Active infections at enrolment or within 30 days prior to enrolment
Acute transplant rejection episodes
Ongoing diarrheal episodes
Patients harbouring HIV and hepatitis B or C infection
Suffering from any malignancy requiring recent surgery or chemotherapy or irradiation
Patients who had received any investigational drug within past six months
History of hypersensitivity to piperine or tacrolimus or MMF
Pregnant women or nursing mothers or women of childbearing potential without an effective method of birth control |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in Cmax (maximum plasma concentration)
Changes in Tmax (time to reach Cmax)
Changes in AUC 0-12 h (area under the concentration-time curve from 0 to 12 hours) |
Baseline and 1 week post intervention administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in Ka
Changes in Kel
Changes in clearance
AUC 0-12 h of piperine at steady state
Incidence and severity of adverse events related to the combination of
tacrolimus, MMF, and piperine
Changes in vital signs, clinical laboratory parameters, or other safety markers over the study duration |
After one week of intervention and patients will be in close follow up at least for the next three months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/11/2025 |
| 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
|
This study evaluates how piperine affects the pharmacokinetics of tacrolimus and mycophenolic acid in kidney transplant patients. These patients often need high doses of immunosuppressants like tacrolimus and MMF due to variability in how their bodies absorb and process these drugs. Both drugs have narrow therapeutic ranges, and maintaining appropriate blood levels is critical to prevent rejection or toxicity. Piperine, a natural compound found in black pepper, is known to enhance the absorption of various drugs by inhibiting enzymes and transporters that reduce drug levels. This study aims to test if piperine can safely increase the blood levels of tacrolimus and MPA in transplant patients, potentially allowing lower doses to be used. Two dosing schedules of piperine are being studied, and outcomes like peak concentration, time to peak, area under the curve, and clearance will be compared before and after piperine use. The ultimate goal is to improve drug effectiveness and safety in renal transplant recipients through dose optimization using piperine as a bioenhancer. |