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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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