NCT04146220: LN

Efficacy of Lower Dose Prednisolone in the Induction of Remission of Lupus Nephritis

Completed Phase 4 Last updated 31 October 2019

What this trial tests

Phase 4 trial testing Prednisolone in Lupus Nephritis in 32 participants. Completed in 30 September 2019.

Timeline

16 July 2018

Primary endpoint
30 September 2019

30 September 2019

Quick facts

Lead sponsor	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	16 July 2018
Primary completion	30 September 2019
Estimated completion	30 September 2019
Sites	1 location across Bangladesh

Drugs / interventions tested

• Prednisolone — full drug profile →

Conditions studied

• Lupus Nephritis — all drugs for Lupus Nephritis →

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Who can join

18 and older, any sex, with Lupus Nephritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Global perspectives on lupus nephritis: a review of clinical trials and therapeutic innovations.
   Xu J, Zhang Y, Huang H, Cao Y. · · 2026 · PMID 42233033 · DOI 10.3389/fimmu.2026.1762892