585
Participants
Start Date
February 15, 2025
Primary Completion Date
August 31, 2029
Study Completion Date
August 31, 2029
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.
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.
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.
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.
Non-steroidal mineralocorticoid receptor antagonist and SoC
Generic drug not available currently. All participants in this arm will receive SoC.
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).
NOT_YET_RECRUITING
Safdarjung Hospital, Ansari Nagar East, Delhi
NOT_YET_RECRUITING
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow
NOT_YET_RECRUITING
Muljibhai Patel Urological Hospital, Nadiād
NOT_YET_RECRUITING
KEM Hospital, Mumbai
NOT_YET_RECRUITING
Nizams Institute of Medical Sciences, Hyderabad
NOT_YET_RECRUITING
Osmania Medical College, Hyderabad
NOT_YET_RECRUITING
JSS Medical College, Mysuru
NOT_YET_RECRUITING
Kasturba Medical College, Manipal, Udupi
NOT_YET_RECRUITING
Madras Medical College, Chennai
NOT_YET_RECRUITING
JIPMER, JIPMER Campus, Puducherry
RECRUITING
Christian Medical College Vellore, Vellore
NOT_YET_RECRUITING
AIIMS Bhubaneswar, Bhubaneswar
Collaborators (2)
Medical Research Council
OTHER_GOV
India Alliance
UNKNOWN
Christian Medical College, Vellore, India
OTHER