Which of the Commonly Available and Approved Drugs in Addition to Standard of Care Can Significantly Improve the Slope of Estimated Glomerular Filtration Rate at Two Years When Compared to Standard of Care Alone in South-Asian Kidney Biopsy-proven Adult (≥18 Years) Primary IgA Nephropathy?

PHASE4RecruitingINTERVENTIONAL
Enrollment

585

Participants

Timeline

Start Date

February 15, 2025

Primary Completion Date

August 31, 2029

Study Completion Date

August 31, 2029

Conditions
IgA NephropathyRenal Insufficiency, ChronicIgA VasculitisIGA Glomerulonephritis
Interventions
DRUG

Oral prednisolone and SoC

Oral prednisolone 0.5 mg/kg per day (maximum, 40 mg/day) for two months, followed by dose tapering by 5mg per day each month for six to nine months. All participants in this arm will receive SoC and oral cotrimoxazole prophylaxis.

DRUG

Gut-directed budesonide and SoC

Gut-directed Budesonide 12 mg once daily for nine months and tapered to 9mg once daily for the next three months, 6mg once daily for the next three months and 3mg once daily for the next three months and stopped (total 18 months). All participants in this arm will receive SoC.

DRUG

Mycophenolate mofetil (MMF) and SoC

Mycophenolate mofetil (MMF) 1.5g/ day for twelve months, followed by 1g/ day for six months (total 18 months). All participants in this arm will receive SoC.

DRUG

Hydroxychloroquine and SoC

Hydroxychloroquine (HCQ) 6.5 mg/kg/day (maximum 400 mg daily) for 24 months. All participants in this arm will receive SoC.

DRUG

Non-steroidal mineralocorticoid receptor antagonist and SoC

Generic drug not available currently. All participants in this arm will receive SoC.

DRUG

SoC defined as maximal labelled or tolerated dose of angiotensin-converting enzyme inhibitor/ angiotensin receptor blocker (ACEi/ARB) & steady dose of sodium-glucose cotransporter-2 inhibitor (SGLT2i)

Maximal labelled or tolerated dose of ACEi/ ARB and a steady dose of SGLT2i (10mg/d of dapagliflozin).

Trial Locations (12)

110029

NOT_YET_RECRUITING

Safdarjung Hospital, Ansari Nagar East, Delhi

226014

NOT_YET_RECRUITING

Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

387001

NOT_YET_RECRUITING

Muljibhai Patel Urological Hospital, Nadiād

400012

NOT_YET_RECRUITING

KEM Hospital, Mumbai

500082

NOT_YET_RECRUITING

Nizams Institute of Medical Sciences, Hyderabad

500095

NOT_YET_RECRUITING

Osmania Medical College, Hyderabad

570004

NOT_YET_RECRUITING

JSS Medical College, Mysuru

576104

NOT_YET_RECRUITING

Kasturba Medical College, Manipal, Udupi

600003

NOT_YET_RECRUITING

Madras Medical College, Chennai

605006

NOT_YET_RECRUITING

JIPMER, JIPMER Campus, Puducherry

632004

RECRUITING

Christian Medical College Vellore, Vellore

751019

NOT_YET_RECRUITING

AIIMS Bhubaneswar, Bhubaneswar

All Listed Sponsors
collaborator

Medical Research Council

OTHER_GOV

collaborator

India Alliance

UNKNOWN

lead

Christian Medical College, Vellore, India

OTHER

NCT06676384 - Which of the Commonly Available and Approved Drugs in Addition to Standard of Care Can Significantly Improve the Slope of Estimated Glomerular Filtration Rate at Two Years When Compared to Standard of Care Alone in South-Asian Kidney Biopsy-proven Adult (≥18 Years) Primary IgA Nephropathy? | Biotech Hunter | Biotech Hunter