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

To study the association of toxic metals, metallothionein, and divalent metal ion transporter gene expression in chronic kidney disease of unknown etiology

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049157
Enrollment
330
Registered
2023-01-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Estimation of toxic metals, metallothionein and divalent metal ion transporter gene expression in both cases and controls: The blood samples will be drawn only at baseline - no follow-u

Sponsors

Dr Namrata Rao S
Lead Sponsor

Eligibility

Inclusion criteria

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: 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.

Design outcomes

Primary

MeasureTime frame
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

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

Countries

India

Contacts

Public ContactNamrata Rao S

Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow

snamratarao@yahoo.co.in09454360872

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026