| 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
|
|
|
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
|
|
|
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. |