FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071002 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 08/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study of chronic kidney disease in a rural area in India 
Scientific Title of Study   Clinico Epidemiological Profile of Patients with CKDu in a Tertiary Care Centre in a Rural Area in Central India 
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 Shubham Dubey 
Designation  Senior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Nephrology, Third Floor, Ward No 30, AVBRH Building, Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  9425393182  
Fax    
Email  shubham_dubey@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manish Balwani 
Designation  Professor and Head of the Department 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Nephrology, Third Floor, Ward No 30, AVBRH Building, Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  9924980546  
Fax    
Email  balwani.manish@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubham Dubey 
Designation  Senior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Nephrology, Third Floor, Ward No 30, AVBRH Building, Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  9425393182  
Fax    
Email  shubham_dubey@rediffmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, Maharashtra, India. 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research  
Address  Sawangi, Wardha, Maharashtra, India. 442001 
Type of Sponsor  Private medical college 
 
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 Shubham Dubey  Datta Meghe Institute of Higher Education and Research  Department of Nephrology, Ward number 29/30, 3rd floor, Acharya Vinoba Bhave Rural Hospital and Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra, India. 442001
Wardha
MAHARASHTRA 		 9425393182

shubham_dubey@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N189||Chronic kidney disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patients of Chronic Kidney Disease between the age of 18 years and 70 years with estimated glomerular filtration rate (eGFR) by creatinine-based CKD Epidemiology Collaboration (CKD-EPIcr2009)equation of 5 mL/min/1.73m2 to 60 mL/min/1.73m2. Patients voluntarily willing to give informed consent will be taken for this study. 
 
ExclusionCriteria 
Details  Patients less than 18 years of age. Patients with other known causes of CKD. Organ transplant recipients. Patients with malignancy. Pregnant females. Patients on current immunosuppressive therapy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study could be
defined as the study of the clinical and epidemiological profile of patients with CKD of Undetermined Etiology(CKDu). 		 Baseline and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes include the study of various biochemical and radiological parameters in patients of CKD of Undetermined Etiology(CKDu).
 		 12 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   05/09/2024 
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="6"
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   The study proposes to study the clinico-epidemiological profile and investigate various biochemical and radiological parameters in patients with chronic kidney disease of Undetermined Etiology (CKDu) in a tertiary care centre in a rural area in Central India. The rationale underscores the importance of understanding the relationship between various epidemiological factors and occurrence of CKDu. The objectives include evaluating various clinical features and epidemiological factors associated with CKDu. Ethical approval and informed consent will be obtained, with data collected through patient history, examination, and laboratory tests. Statistical analysis will be conducted using SPSS software. The study aims to contribute valuable insights into the epidemiological features associated with CKDu patients, potentially informing preventive and clinical management strategies.  
Close