| CTRI Number |
CTRI/2025/11/097983 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
23/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Measurement of GFR using protein load] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding How a Donor’s Kidney Adapts and Works Six Months After Donating One Away |
|
Scientific Title of Study
|
Renal reserve and its association with renal function at 6 months post living kidney donation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Ganwani |
| Designation |
Senior resident |
| Affiliation |
PGIMER |
| Address |
Doctors duty room, ground floor, C block, Nehru hospital, Department of Nephrology, PGIMER, Sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
9405322774 |
| Fax |
|
| Email |
amit.h.ganwani@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof. Dr. Harbir Singh Kohli |
| Designation |
Head of Department |
| Affiliation |
PGIMER |
| Address |
HOD Office, C block, Ground floor, Nehru hospital, Department of Nephrology, PGIMER, Sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
9417525285 |
| Fax |
|
| Email |
kohlihs2009@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Amit Ganwani |
| Designation |
Senior resident |
| Affiliation |
PGIMER |
| Address |
Doctors duty room, ground floor, C block, Nehru hospital, Department of Nephrology, PGIMER, Sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
9405322774 |
| Fax |
|
| Email |
amit.h.ganwani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Departmental fund, Department of Nephrology, PGIMER |
|
|
Primary Sponsor
|
| Name |
Department of Nephrology |
| Address |
PGIMER, Sector 12, Chandigarh 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 |
| Amit Ganwani |
PGIMER |
Central processing unit lab, Level 2, C block, Nehru hospital Chandigarh CHANDIGARH |
9405322774
amit.h.ganwani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural) |
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 |
| Intervention |
Measurement of GFR using plasma iohexol clearance. |
Baseline GFR will be measured using plasma iohexol clearance. Stress GFR will be measured after 7 days by giving oral milk based protein supplement 1gm/kg. GFR will be measured 6 months after kidney donation |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 50 years
Voluntary kidney donor |
|
| ExclusionCriteria |
| Details |
1. Subjects with pre-existing comorbidities or history of systemic hypertension, diabetes mellitus, coronary artery disease, chronic obstructive pulmonary disease, renal stone disease or chronic liver disease
2. History of active malignancy or treatment for malignancy in the past
3. Pregnancy, in case of females
4. History of voiding dysfunction
5. Allergy to iohexol or iodinated contrast media
6. Subjects with lactose intolerance or allergy to milk / milk based products |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure renal functional reserve using iohexol clearance using protein load in prospective living kidney donors before kidney donation |
To measure renal functional reserve in prospective living kidney donors and its association with renal function 6 months post kidney donation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To ascertain association of pre-donation renal functional reserve with measured GFR at 6 months after kidney donation in living kidney donors
2) To ascertain bias between measured GFR & estimated GFR (by CKD-EPICr 2021) at 6 months after kidney donation in living kidney donors |
Baseline, day 7 & 6 months post kidney donation |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
04/12/2025 |
| 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="0" Months="9" 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
|
Serum creatinine and glomerular filtration rate (GFR) are currently used to measure kidney function in clinical practices. The baseline GFR does not reflect full kidney function as kidney does not work at its maximum capacity under normal conditions. GFR increases acutely after heavy protein load and the increase represents recruitment of reserve. This increase is called renal functional reserve (RFR). It has been shown that measured GFR in normal individuals of Indian ethnicity is lower than that in Western population. It is not known whether that is physiological or pathological. Plasma clearance of iohexol is the current gold standard for measurement of GFR. We have already established procedures for measurement of GFR by plasma clearance of iohexol. Assessment of RFR, using most accurate reference method to measure GFR such as plasma disappearance of iohexol, is important to ascertain significance of low normal GFR in Indian population. The proposed study aims to evaluate RFR of healthy Indian subjects after protein load using standard method of measurement of GFR i.e. using plasma iohexol clearance. We propose to measure the RFR in prospective living renal donors who are extensively worked up to assess normality of clinical status. Pre and Post protein loading GFR will be measured by multiple sample plasma clearance of iohexol. Iohexol will be analyzed by HPLC. We aim to analyse association of RFR with post kidney donation renal function at 6 months in living renal donors. |