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Clinical correlations of kidney biopsies among patients with unexplained chronic kidney disease to aid better understanding of unexplained chronic kidney disease in the region

Clinicopathologic correlation of kidney biopsies done in patients with unexplained chronic kidney disease a prospective observational study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/07/090222
Enrollment
100
Registered
2025-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: N189- Chronic kidney disease, unspecified

Interventions

Intervention1: Nil: Nil

Sponsors

Dr Namrata Rao S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The diagnosis of unexplained chronic kidney disease will be made using: 1. Those with short duration of renal-specific symptoms and no baseline renal function tests available 2. Those with short duration of hypertension and no ophthalmoscopic findings of hypertensive retinopathy 3. Those with normal sized kidneys with/ without alterations of corticomedullary echotexture on ultrasound examination, but no urinary tract obstruction, stones, multiple cysts (defined as the presence of three or more (unilateral or bilateral) renal cysts in individuals aged 15 to 39 years, two or more cysts in each kidney is sufficient for individuals aged 40 to 59 years, and four or more cysts in each kidney is required for individuals more than 60 yr.)or single kidney 4. Those with non-nephrotic proteinuria with/without urinary sediment changes 5. Non-diabetic/ Diabetic without diabetic retinopathy 6. No previous kidney biopsy suggestive of another basic kidney disease Screening inclusion criteria :Patients Decisioned for kidney biopsy for unexplained renal failure , per institutional protocol, by treating nephrologist (eGFR less than 60 ml/min/1.73m2) with/without urinary sediment abnormalities, who 1. are adults more than 18 years of age 2. giving informed consent for participation in study Final inclusion criteria: 1. Availability of baseline eGFR 3 months or earlier less than 60 ml/min/1.73 m2 or 2. For study participants without baseline eGFR, follow-up for next 3 months with follow-up eGFR less than 60 ml/min/1.73 m2

Exclusion criteria

Exclusion criteria: Patients not fulfilling institutional criteria for unexplained renal failure (positive serologies, underlying diabetes mellitus with diabetic retinopathy, longstanding hypertension with more than two anti-hypertensive drug use and presence of hypertensive retinopathy, long-term use of NSAIDs, among others)

Design outcomes

Primary

MeasureTime frame
To estimate the prevalence of chronic tubulointerstitial inflammation and/or fibrosis (CTIN) among renal biopsies performed in patients for unexplained renal failure having chronic kidney diseaseTimepoint: To estimate the prevalence of chronic tubulointerstitial inflammation and/or fibrosis (CTIN) among renal biopsies performed in patients for unexplained renal failure having chronic kidney disease - of successive patients for study duration of 2 years

Secondary

MeasureTime frame
To examine clinical characteristics that can predict chronic tubulointerstitial nephritis on renal biopsyTimepoint: To examine clinical characteristics that can predict chronic tubulointerstitial nephritis on renal biopsy - of successive patients for study duration of 2 years;To compare the serum levels of heavy metals between groups of patients with chronic kidney disease designated as chronic tubulointerstitial nephritis, chronic glomerulonephritis and combined findings (chronic tubulointerstitial nephritis and glomerulosclerosis)Timepoint: To compare the serum levels of heavy metals between groups of patients with chronic kidney disease designated as chronic tubulointerstitial nephritis, chronic glomerulonephritis and combined findings (chronic tubulointerstitial nephritis and glomerulosclerosis) - of successive patients for study duration of 2 years

Countries

India

Contacts

Public ContactNamrata Rao S

Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow

vinayps589@gmail.com9140070226

Outcome results

None listed

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