Toxic metals and their accumulation in relation to Chronic Kidney Disease of unknown etiology

Not Applicable

• Conditions: Health Condition 1: N039- Chronic nephritic syndrome with unspecified morphologic changesHealth Condition 2: N119- Chronic tubulo-interstitial nephritis, unspecifiedHealth Condition 3: N08- Glomerular disorders in diseases classified elsewhere

• Registration Number: CTRI/2023/01/049157
• Lead Sponsor: Dr Namrata Rao S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

For CKDu - none of the conditions from exclusion criteria should be present

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

Exclusion Criteria

Exclusion criteria include the presence of CKD due to any of the etiologies mentioned as below:

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 â??syndromesâ?? will be diagnosed by characteristic clinical findings, family history, and laboratory abnormalities.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the serum levels of heavy metals and metabolizing enzymes, metallothionein and DMT1 among CKDu cases and known CKD controlsTimepoint: Only at baseline - no follow-up

Secondary Outcome Measures

Name	Time	Method
To compare environmental and occupational risk factors between patients showing elevated levels of heavy metals and patients without elevated levelsTimepoint: 2 years