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CTRI Number  CTRI/2025/10/096050 [Registered on: 14/10/2025] Trial Registered Prospectively
Last Modified On: 13/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Understanding Chronic Kidney Disease of Unknown Origin in Chhattisgarh: Epidemiology, Risk factor and Preventive strategies 
Scientific Title of Study   Understanding Chronic Kidney Disease of Unknown Origin in Chhattisgarh: Hospital and Community level Detection, Epidemiology, Risk Factors and Prevention Strategies. 
Trial Acronym  CKDu 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinay Rathore 
Designation  Associate Professor 
Affiliation  AIIMS Raipur 
Address  Gate no.4, C Block, Ground floor, Nephrology OPD,AIIMS, G.E. Road, Tatibandh, Raipur, Chhattisgarh

Raipur
CHHATTISGARH
492099
India 
Phone  09914699651  
Fax    
Email  vinayrathoredm@aiimsraipur.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Vinay Rathore 
Designation  Associate Professor 
Affiliation  AIIMS Raipur 
Address  Gate no.4, C Block, Ground floor, Nephrology OPD,AIIMS, G.E. Road, Tatibandh, Raipur, Chhattisgarh

Raipur
CHHATTISGARH
492099
India 
Phone  09914699651  
Fax    
Email  vinayrathoredm@aiimsraipur.edu.in  
 
Details of Contact Person
Public Query  
Name  Vinay Rathore 
Designation  Associate Professor 
Affiliation  AIIMS Raipur 
Address  Gate no.4, C Block, Ground floor, Nephrology OPD,AIIMS, G.E. Road, Tatibandh, Raipur, Chhattisgarh

Raipur
CHHATTISGARH
492099
India 
Phone  09914699651  
Fax    
Email  vinayrathoredm@aiimsraipur.edu.in  
 
Source of Monetary or Material Support  
INDIAN COUNCIL OF MEDICAL RESEARCH (Young Faculty PhD Program 2024-2025) 
 
Primary Sponsor  
Name  INDIAN COUNCIL OF MEDICAL RESEARCH (Young Faculty PhD Program 2024-2025) 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
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 Vinay Rathore  AIIMS Raipur  Gate no. 4, C-Block, Ground Floor, Department of Nephrology, AIIMS, G.E. Road, Tatibandh, Raipur, Chhattisgarh, 492099
Raipur
CHHATTISGARH 		 9914699651

vinayrathoredm@aiimsraipur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N119||Chronic tubulo-interstitial nephritis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with diagnosis of CKDu and age, sex and stage of Kidney disease matched controls 
 
ExclusionCriteria 
Details  Patients with Acute Kidney injury 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mortality during the study period.
Rate of decline of GFR  		 Time point of assessment: Every 6 monthly after enrollment for three years.
At 6 month, 12 months, 18 month, 24 months, 30 months, 36 months. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   01/11/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

· Background:  In recent years several geographical hotspots of Chronic Kidney Disease have been identified where CKD is not due to known traditional causes like diabetes and hypertension and has been aptly called CKD of Unknown Origin (CKDu). Recent reports from AIIMS Raipur have identified such hotspots in the Gariyaband and Mahasamund districts of Chhattisgarh. However, the identification and etiology and thereby the preventive strategies for CKDu are hampered by the lack of both hospital-based and community-based well-designed cohort and longitudinal studies.

 

Purpose: The purpose of this study is to 

·         Determine the clinical profile of CKDu by forming a Hospital and Community based Cohort of CKDu patients

·          To determine the prevalence and incidence of CKDu.

·          To determine the outcomes and natural history of progression of CKDu

·         To determine the risk factors and underlying causes of CKDu. 

Rationale:  In recent years several geographical hotspots of Chronic Kidney Disease have been identified where CKD is not due to known traditional causes like diabetes and hypertension and has been aptly called CKD of Unknown Origin (CKDu). Recent reports from AIIMS Raipur have identified such hotspots in the Gariyaband and Mahasamund districts of Chhattisgarh. However, the identification and etiology and thereby the preventive strategies for CKDu are hampered by the lack of both hospital-based and community-based well-designed cohort and longitudinal studies.

·         Novelty: To our knowledge, there is no community-based or cohort study in CKDu from central India. The study will also look into various risk factors including host-related, environmental, and genetic risk factors associated with CKDu. 

·         Objectives:  The primary aim of the study will be to determine the community-level prevalence and risk factors (epidemiological, behavioral, environmental, and genetic risk factors) of CKDu in the endemic village of Chhattisgarh and the secondary objective will be to develop a cohort of CKDu patients for prospective follow-up to determine the rate of GFR decline thereby developing a strategy for the prevention and treatment of CKDu.

·         Methods:

·         The study proposes cross section screening for CKD using serum creatinine and Urine Protein Creatinine ratio of identified village reporting the highest number of CKDu at AIIMS Raipur for using a randomsampling technique to determine the prevalence of CKD and CKDu.

·         The study also proposes to form a Hospital-based Case-Cohort of CKDu patients fulfilling the case definition of CKDu visiting AIIMS Raipur and a comparative cohort of CKD patients with a known traditional cause of CKD like diabetes and hypertension.

·         Socio-demographic, environmental history, medical, family, treatment history, and physical examination including anthropometric parameters and blood pressure will be collected. Biological Sample Collection including blood, urine, hair, and nail samples will be collected.

·         Laboratory studies will include random blood sugar, HbA1C, complete blood count, sickling test, urinary protein-creatinine ratio, urine routine microscopy, urine electrolytes, serum sodium, potassium, chloride, urea, creatinine, uric acid, fasting urine and serum osmolality, magnesium, and eGFR. and USG KUB will be done in all hospital-based cohorts. Additionally, random samples (10%) will be subjected to testing for heavy metal (Lead, Mercury, Lithium, Chloride, Arsenic, Chromium, Cadmium, Nickle), agrochemical (Fertilizer, Paraquat), and genetic analysis (Whole Exome Sequencing).

·         The cohort will be followed up at AIIMS Raipur to determine the trajectory of GFR.

·         Data will be compared with a comparative cohort of CKD of traditional causes to find out epidemiological, behavioral, and medical risk factors of CKD patients with those of the individuals with CKD due to known causes. The environmental (heavy metals, pesticides) and genetic factors (whole exome sequencing) will be compared to patients with those with CKD due to known causes.

·         Preventive and treatment strategies will be developed based on the outcomes of the above phase and will be shared with the community for implementation

·         Expected outcome: The study is expected to find out the prevalence of CKD and CKDu  anduncover the specific risk factors (host and, environmental specific) for CKDu which may differ from those in other hotspots. The Cohort study should find out the rate of decline of GFR in this cohort of patients

 
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