Efficacy of Lower Dose Prednisolone in the Induction of Remission of Lupus Nephritis
Status:
Completed
Trial end date:
2019-09-30
Target enrollment:
Participant gender:
Summary
The LN is a common cause of mortality and morbidity in SLE. The use of high-dose
glucocorticoids (GC) with an immunosuppressive agent is usual practice for treating this
condition. Higher dose of GC use might cause adverse effects along with clinical improvement.
Studies had reported comparable outcome of lower dose of GC with minimum side effects. The
aim of this study was to determine the outcome of lower dose prednisolone in the induction of
remission of proliferative LN.
This prospective, clinical trial was conducted in Rheumatology outpatient and inpatient
department of BSMMU from July 2018 to September 2019. Thirty-two subjects were enrolled after
having informed consent. The ACR (American College of Rheumatology) criteria was followed for
diagnosis of SLE. The patients of both genders, age ≥18 years, who fulfilled the ACR criteria
of LN and unable to afford MMF were enrolled.
The patient evaluation tool was SELENA-DAI and Bengali version of SF-12 questionnaire. The
24-hour urinary protein, urine R/M/E, serum creatinine, CBC, serum C3, C4 levels and
anti-dsDNA were done at baseline and at final visit of the study.
All patients received pulse I/V methylprednisolone 500 mg/day daily for 3 doses. After then
experimental group received oral prednisolone 0.5 mg/kg/day and control group received oral
prednisolone 1 mg/kg/day for a period of 4 weeks. After then the prednisolone was tapered by
10 mg/day in every two weeks until 40 mg/day, then 5 mg/day in every two weeks until 10
mg/day is reached, after two weeks the dose was tapered by 2.5 mg/day to a maintenance dose
of 7.5 mg/day. Both groups were treated in the background of hydroxychloroquine (HCQ),
angiotensin receptor blocker (ARB) and pulse I/V cyclophosphamide (CYC) for 6 cycle.
The ethical clearance was obtained from Institutional Review Board (IRB) of BSMMU and
technical clearance was taken from rheumatology technical board.
Phase:
Phase 4
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh