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CTRI Number  CTRI/2025/10/096353 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 22/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Checking for early kidney problems in children with cancer taking treatment 
Scientific Title of Study   Correlation of urinary KIM-1 and NAG with Serum Creatinine for early detection of Acute kidney injury in Pediatric cancer patients receiving chemotherapy-A one year cross sectional study in Belagavi 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gouri M Patil  
Designation  Postgraduate 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Pediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital road Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8310839273  
Fax    
Email  drgourimpatil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MAHANTESH V PATIL 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College 
Address  Pediatric Nephrologist, Department of Pediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital road Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9483561674  
Fax    
Email  drmahanteshvpatil@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gouri M Patil  
Designation  Postgraduate 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Pediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital road Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8310839273  
Fax    
Email  drgourimpatil@gmail.com  
 
Source of Monetary or Material Support  
KLEs Dr. Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, KLE University, Belagavi, Karnataka, 590010 
 
Primary Sponsor  
Name  Dr Gouri M Patil 
Address  Department of pediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE hospital road Belagavi 
Type of Sponsor  Other [Self] 
 
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 
Dr Gouri M Patil  KLEs Dr. PRABHAKAR KORE HOSPITAL BELAGAVI  Department of Pediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital road
Belgaum
KARNATAKA 
8310839273

drgourimpatil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N179||Acute kidney failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children aged 1- 18 years diagnosed with malignant diseases and receiving chemotherapy agents with renal route of excretion causing Acute Kidney Injury like (ex: methotrexate, cisplatin, carboplatin etc.) and Chemotherapy agents causing with non-renal route of excretion causing Acute Kidney Injury (Vincristine, Cytarabine, Etoposide etc. ) at KLE Hospital, Belagavi. 
 
ExclusionCriteria 
Details  Pre-existing CKD
Structural renal anomalies.
Post – Nephrectomy
Renal tumors.
Who have received nephrotoxic antibiotics greater than 10 days.
Administration of contrast medium in the previous 14 days.
Incomplete data or refusal of consent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To correlate the efficacy of selected urinary biomarker’s i.e. urinary KIM-1 and urinary NAG with serum creatinine in the early detection of Acute Kidney Injury (AKI) among pediatric cancer patients receiving chemotherapy agents.  0 hours and 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1 To determine the risk factors of Acute Kidney Injury in pediatric oncology patients receiving chemotherapy
2 To evaluate the diagnostic timeline of biomarkers like KIM1 And NAG at baseline 0 hour before chemotherapy And 24 hours post chemotherapy with elevation of serum creatinine
3 To assess the stage of Acute Kidney Injury as per KIDGO criteria
 
NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   03/11/2025 
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="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  

Acute Kidney Injury AKI is a prevalent and serious condition associated with significant morbidity and mortality. It affects 30 to 50 percent of critically ill patients and those requiring renal replacement therapy have a mortality rate exceeding 50 percent. Among pediatric oncology patients AKI is a common complication affecting approximately 15 to 25 percent of patients. It can be caused by chemotherapeutic agents such as cisplatin methotrexate and ifosfamide as well as by sepsis dehydration and tumor lysis syndrome. Early detection of AKI is crucial to prevent progression to chronic kidney disease dialysis dependency and increased morbidity and mortality.

Currently serum creatinine is the most commonly used marker for detecting AKI. However it has significant limitations due to its low sensitivity and specificity. Its levels can be influenced by various factors including age sex muscle mass hydration status and dietary intake. Moreover it tends to rise only after substantial kidney injury has occurred and often with a delay.

Recent research has highlighted the potential of novel urinary biomarkers such as kidney injury molecule-1 uKIM-1 and N-acetyl-beta-D-glucosaminidase uNAG in identifying early tubular damage before changes in serum creatinine occur. These biomarkers can detect subclinical forms of AKI thereby allowing for earlier intervention.

The aim of our study is to evaluate the incidence of AKI including subclinical AKI in pediatric oncology patients undergoing chemotherapy and to assess the diagnostic utility of urinary biomarkers uKIM-1 and uNAG compared to serum creatinine in the early detection of AKI.

 
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