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CTRI Number  CTRI/2023/01/049117 [Registered on: 19/01/2023] Trial Registered Prospectively
Last Modified On: 16/01/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   CKDu prevalence in eastern Uttar Pradesh 
Scientific Title of Study   Estimation of prevalence of chronic kidney disease of undetermined etiology (CKDu) in eastern Uttar Pradesh using hospital-based registry 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Namrata Rao S 
Designation  Associate Professor 
Affiliation  Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow 
Address  Department of Nephrology, Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  09454360872  
Fax    
Email  snamratarao@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Namrata Rao S 
Designation  Associate Professor 
Affiliation  Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow 
Address  Department of Nephrology, Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  09454360872  
Fax    
Email  snamratarao@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Namrata Rao S 
Designation  Associate Professor 
Affiliation  Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow 
Address  Department of Nephrology, Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  09454360872  
Fax    
Email  snamratarao@yahoo.co.in  
 
Source of Monetary or Material Support  
Dr Ram Manohar Lohiya Institute of Medical Sciences, Lucknow 
 
Primary Sponsor  
Name  Dr Namrata Rao S 
Address  Department of Nephrology, Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow - 226010 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
None  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Namrata Rao  Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow  Department of Nephrology, Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow - 226010
Lucknow
UTTAR PRADESH 
09454360872

snamratarao@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow  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 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Exclusion of all known causes of CKD as per protocol (described)
Mandatory criteria: eGFR < 60 ml/min/1.73 m2 by CKD-EPI formula + ultrasonography (USG) showing small shrunken kidneys and/or Renal biopsy done shows chronic tubulointerstitial nephritis with no immune deposits + No exclusion criteria (detailed below) 
 
ExclusionCriteria 
Details  Stable patients attending Nephrology OPD and diagnosed with chronic kidney disease (CKD) as per the KDIGO criteria definition, are enrolled in the hospital CKD registry. Etiologic workup for cause of CKD would be done as per institutional protocol which is as follows (upon which patient will be excluded):

a.) Diabetic kidney disease: Diabetes mellitus identified using American Diabetes Association (ADA) criteria for fasting and postprandial blood glucose levels or if the patient has been receiving hypoglycemic agents and has fundus findings of diabetic retinopathy alongwith proteinuric kidney disease (urinary protein excretion of > 1.5 g/day or dipstick value of ++ or more), or has renal biopsy findings of diabetic nephropathy, will be presumed to have diabetic kidney disease.

b.) Hypertensive nephrosclerosis: CKD will be attributed to hypertensive nephrosclerosis if the patient had documented systemic hypertension for >5 years before the diagnosis of CKD or with severe hypertension (requiring more than 2 antihypertensives or blood pressure >160/100 mm Hg) or fundus findings of chronic hypertensive retinopathy at any time in the absence of other causes of CKD.

c.) Chronic glomerulonephritis: Chronic glomerulonephritis will be diagnosed if kidney biopsy shows evidence of glomerulonephritis or if a patient with CKD had a history of long-standing edema and/or proteinuria > ++ or >1.5 g/day.

d.) Chronic tubulointerstitial nephritis: The diagnosis of chronic tubulointerstitial disease will be made either on histology or based on a compatible history, the presence of vesicoureteral reflux, and/or recurrent urinary tract infection.

e.) Others: Obstructive uropathy, renal stone diease, and cystic disease will be diagnosed if there are confirmatory findings seen on imaging studies. The diagnosis of renovascular disease will be made from Doppler study or angiography. Kidney disease in association with specific “syndromes” will be diagnosed by characteristic clinical findings, family history, and laboratory abnormalities.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the prevalence of chronic kidney disease of undetermined etiology (CKDu) among the patients visiting the hospital in a time period of 2 years  Baseline (cross-sectional study) 
 
Secondary Outcome  
Outcome  TimePoints 
To localize cases of CKDu according to village, Tehsil and district to identify disease clusters, if any  2 years 
 
Target Sample Size   Total Sample Size="700"
Sample Size from India="700" 
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)   25/01/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [snamratarao@yahoo.co.in].

  6. For how long will this data be available start date provided 11-10-2025 and end date provided 10-10-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Chronic kidney disease (CKD) is an increasingly common cause of morbidity and mortality worldwide. While diabetes mellitus and hypertension account for a majority of CKD, a proportion of CKD burden especially in tropical countries like India, is accounted for by CKD of undetermined etiology (CKDu). (1) CKDu has been described in endemic hotspots globally for last few decades, appearing as a chronic interstitial nephritis in predominantly agricultural communities in tropical climates such as India, Sri Lanka, and many South and Central American countries. Majority of reports of CKDu in India come from southern India, where the climate remains hot and humid through the year, however, CKD hotspots have been described in Kanpur from Uttar Pradesh, and in Chattisgarh and Punjab too, where temperature and relative humidity dip significantly in the winter months. Whether these northern Indian hotspots correspond to CKDu or not, is presently unclear. (2)

Presently, the department of Nephrology runs six outpatient clinics a week catering to patients coming from the neighbouring districts in eastern Uttar Pradesh, with a hospital-based registry for patients with CKD, a proportion of whom correspond to CKDu. With the current advances in geolocalisation, identified cases of CKDu can be mapped down to their street and home address. At the outset, the study will estimate the prevalence of CKDu among the patients visiting this hospital, and later might identify CKDu hotspots if any, in this region, which is climatically and ethnogeographically different than areas previously identified.

 
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