| CTRI Number |
CTRI/2022/01/039109 [Registered on: 04/01/2022] Trial Registered Prospectively |
| Last Modified On: |
30/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Safety of low dose Ramipril in voluntary kidney donors after donation. |
|
Scientific Title of Study
|
Safety of low dose ACE inhibition in living kidney donors. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankur Chaudhary |
| Designation |
Senior resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of nephrology, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9569974047 |
| Fax |
|
| Email |
cool_doc_ankur@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Kumar |
| Designation |
Associate Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Nephrology, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087429731 |
| Fax |
|
| Email |
enigma165@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankur Chaudhary |
| Designation |
Senior resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of nephrology, PGIMER, Chandigarh
CHANDIGARH
160012
India |
| Phone |
9569974047 |
| Fax |
|
| Email |
cool_doc_ankur@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Nephrology, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Nephrology |
| Address |
PGIMER, Chandigarh |
| 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 Ankur Chaudhary |
PGIMER, Chandigarh |
Department of Nephrology, C- block, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
9569974047
cool_doc_ankur@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Voluntary kidney donors |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Nil |
| Intervention |
Ramipril 1.25mg |
Low dose ACE inhibitor Ramipril 1.25mg will be given to live kidney donors post donation for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) age 18 to 60 years |
|
| ExclusionCriteria |
| Details |
1) diagnosis of hypertension
2) history of allergy to ACE inhibitors
3) History of angioedema
4) history of allergy to iodinated contrast media
5) systolic BP < 100mm Hg
6)Planning pregnancy in next 9 months after renal donation (females) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate safety of low dose ACEi (Ramipril 1.25mg) in living kidney donors. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To ascertain change in measured GFR in living donors at 6 months after kidney donation by plasma clearance of Iohexol |
6 months |
| To ascertain change in vascular stiffness in living donors at 6 months after kidney donation by PWV |
6 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
05/01/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this open label, randomised clinical trial, we propose to explore the safety of low dose ACE inhibitor ie. Ramipril 1.25mg in renal donors post donation and their possible effects on arterial stiffness and measured GFR. We will measure GFR, aortic stiffness and FMD in donors, pre donation and post donation. After informed consent (as in Annexure 3), all clinical investigations will be recorded and within 14 days post nephrectomy, measured GFR, PVW and FMD will be assessed. Subjects will be randomised into two groups with one receiving low dose Ramipril 1.25mg while other group serving s control with no medication. Subjects shall be reassessed after 6 months for any adverse effects and changes in measured GFR using Iohexol clearance, arterial stiffness using PWV and FMD. If a significant benefit of ACE inhibitor is documented on reducing aortic stiffness which is a surrogate marker of cardiovascular risk, than it will be worthwhile to prescribe ACE inhibitors routinely to all post renal donation patients.
|