| 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
|
|
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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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - None of the above
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [snamratarao@yahoo.co.in].
- 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.
- 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. |