IgA nephropathy study in Indians

Why is IgA nephropathy aggressive in Indians? Study of the effect of galactose deficient IgA1, anti-glycan antibodies including immune complexes and complement components on the rate of progression of renal disease.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN36834159

Enrollment

500

Registered

2017-10-11

Start date

2015-03-09

Completion date

Unknown

Last updated

2023-12-04

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

Conditions

Chronic kidney disease and IgA nephropathy (IgAN) Urological and Genital Diseases Chronic kidney disease

Interventions

200 IgAN patients will be recruited and classified into low and high risk groups based on a validated risk score. High risk IgAN group are IgAN patients with an Absolute Renal Risk (ARR) score of =23

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Primary IgA nephropathy diagnosed by renal biopsy 3. Written informed consent 4. Willing to come for follow-up visits 5. Immunosuppression naive for three months prior to recruitment

Exclusion criteria

Exclusion criteria: 1. Secondary IgA nephropathy: e.g. due to lupus, liver cirrhosis, Henoch-Schonlein purpura 2. Glomerular filtration rate (GFR) as estimated by the CKD-EPI equation <10ml/min/1.73m2 3. Participants with systemic diseases that can affect the kidneys like diabetes, systemic lupus erythematosus, presence of HIV, HbsAg, HCV infections, malignancies etc 4. Participants with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study

Design outcomes

Primary

Measure	Time frame
1. Levels of serum Gd-IgA1 and AGlyIgA including immune complexes, measured using ELISA at baseline and annually 2. Rate of progression of IgAN, measured by the rate of fall in estimated glomerular filtration rate (eGFR) estimated by the CKD-EPI creatinine equation measured annually till composite end-point or end of follow-up (average of five years)	—

Secondary

Measure	Time frame
1. Composite end-point of 50% decline in eGFR, ESKD or death, whichever occurs earlier, measured using CKD-EPI creatinine equation and ESKD defined as eGFR by CKD-EPI creatinine equation <15ml/min/1.73m2 and/or requiring renal replacement therapy 2. Co-deposition of components of the lectin and alternative pathway of complement activation in renal biopsies, measured by immunofluorescence and immunohistochemistry at baseline 3. Proteinuria, measured using 24 hour urine protein (g/day) at baseline and annually till composite end-point or end of follow-up (average of five years)	—

Measure

Time frame

1. Composite end-point of 50% decline in eGFR, ESKD or death, whichever occurs earlier, measured using CKD-EPI creatinine equation and ESKD defined as eGFR by CKD-EPI creatinine equation <15ml/min/1.73m2 and/or requiring renal replacement therapy 2. Co-deposition of components of the lectin and alternative pathway of complement activation in renal biopsies, measured by immunofluorescence and immunohistochemistry at baseline 3. Proteinuria, measured using 24 hour urine protein (g/day) at baseline and annually till composite end-point or end of follow-up (average of five years)

—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026