Estimation of prevalence of chronic kidney disease of undetermined etiology (CKDu) in eastern Uttar Pradesh using hospital-based registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief Summary
Chronickidney disease (CKD) is an increasingly common cause of morbidity and mortalityworldwide. While diabetes mellitus and hypertension account for a majority ofCKD, a proportion of CKD burden especially in tropical countries like India, isaccounted for by CKD of undetermined etiology (CKDu). (1) CKDu has beendescribed in endemic hotspots globally for last few decades, appearing as achronic interstitial nephritis in predominantly agricultural communities intropical climates such as India, Sri Lanka, and many South and Central Americancountries. Majority of reports of CKDu in India come from southern India, wherethe climate remains hot and humid through the year, however, CKD hotspots havebeen 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 presentlyunclear. (2)
Presently,the department of Nephrology runs six outpatient clinics a week catering topatients coming from the neighbouring districts in eastern Uttar Pradesh, witha hospital-based registry for patients with CKD, a proportion of whomcorrespond to CKDu. With the current advances in geolocalisation, identifiedcases of CKDu can be mapped down to their street and home address. At theoutset, the study will estimate the prevalence of CKDu among the patientsvisiting this hospital, and later might identify CKDu hotspots if any, in thisregion, which is climatically and ethnogeographically different than areaspreviously identified.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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
Time Frame: Baseline (cross-sectional study)
Secondary Outcomes
- To localize cases of CKDu according to village, Tehsil and district to identify disease clusters, if any(2 years)