Skip to content

A study comparing oral hydroxychloroquine and supportive treatment with supportive treatment alone for management of IgA nephropathy

A prospective multi-centric randomized open label trial to assess efficacy of Hydroxychloroquine (HCQ) in reducing proteinuria in moderately severe primary IgA Nephropathy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/034929
Enrollment
102
Registered
2021-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: N289- Disorder of kidney and ureter, unspecified

Interventions

Intervention1: Oral Hydroxychloroquine: Patients will receive oral HCQ (hydroxychloroquine sulfate tablets
Immulast provided by Cipla Pharmaceutical Co, Ltd) in a dose of 400mg/day(300mg/day if weight60kg) for 6 months along with optimized dose of ACEi/ARB Control Intervention1: Supportive therapy: Patien

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients(=18 years AND 2. Persistent urinary protein creatinine ratio >1g/g but less than 3.5g/g 3. eGFR=45 ml/min/1.73m2 as calculated by the chronic kidney disease epidemiology collaboration creatinine equation (CKD-EPI) 4. Has been on ACEi/ARB therapy for at-least 6 months in maximal tolerated dose

Exclusion criteria

Exclusion criteria: 1. Use of immunosuppression in the past 6 months 2. IgAN requiring immunosuppression like crescentic IgAN or IgA vasculitis 3. Current or planned pregnancy or lactation 4. Concomitant systemic disease like diabetes, chronic liver disease, malignancy, any cardiac or cerebrovascular disease 5. Retinopathy 6. G6PD deficiency 7. Unwilling to give consent

Design outcomes

Primary

MeasureTime frame
•The primary outcome studied will be the proportion of patients who achieve remission(complete/partial) at the end of 6 months in both the groups. Timepoint: At 6 months

Secondary

MeasureTime frame
The secondary outcome will be (1) Difference in the percentage reduction in proteinuria between the two groups (2) Difference in renal survival defined as decline in eGFR of 40% or progression to end stage renal disease(ESRD) at the end of 6 months between the two groups Timepoint: At 6 months

Countries

India

Contacts

Public ContactSoumita Bagchi

Department of Nephrology

soumita_bagchi@yahoo.co.in01126596434

Outcome results

None listed

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