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Corticosteroid

Mycophenolate Mofetil/Mycophenolic Acid for Lupus Nephritis

Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1), weeks 4, 12, 24, 36, 52
Awards & highlights

Study Summary

This trial will compare the effectiveness and safety of a combination of drugs including obinutuzumab with mycophenolate mofetil/mycophenolic acid, to a placebo combined with mycophenolate mofetil/mycophenolic acid, in people with proliferative lupus nephritis.

Eligible Conditions
  • Lupus Nephritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), weeks 4, 12, 24, 36, 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1), weeks 4, 12, 24, 36, 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Achieve Protocol Defined Complete Renal Response (CRR) at Week 52
Secondary outcome measures
Area Under the Plasma Concentration Versus Time Curve (AUC) of Obinutuzumab
Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody Levels at Week 52
Change From Baseline in C4 Levels at Week 52
+18 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ObinutuzumabExperimental Treatment4 Interventions
Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
Group II: PlaceboPlacebo Group4 Interventions
Participants will receive placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate Mofetil/Mycophenolic Acid
2015
Completed Phase 2
~130
Obinutuzumab
2015
Completed Phase 3
~3250
Methylprednisolone
2015
Completed Phase 4
~2280
Prednisone
2014
Completed Phase 4
~2370

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,928 Total Patients Enrolled
5 Trials studying Lupus Nephritis
730 Patients Enrolled for Lupus Nephritis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,376 Total Patients Enrolled
6 Trials studying Lupus Nephritis
1,111 Patients Enrolled for Lupus Nephritis

Media Library

Methylprednisolone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02550652 — Phase 2
Lupus Nephritis Research Study Groups: Obinutuzumab, Placebo
Lupus Nephritis Clinical Trial 2023: Methylprednisolone Highlights & Side Effects. Trial Name: NCT02550652 — Phase 2
Methylprednisolone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02550652 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential harms could be caused by Mycophenolate Mofetil/Mycophenolic Acid consumption?

"With Phase 2 trials indicating a degree of safety, Mycophenolate Mofetil/Mycophenolic Acid has been determined to have an estimated risk rating of 2."

Answered by AI

Is admission to the trial open at this time?

"This medical study is no longer accepting applications; its posting date of November 13th 2015 and last update on the 14th of Novemeber 2022 indicate that recruitment has concluded. Individuals wishing to participate in clinical trials with lupus nephritis as their focus can look at 39 active studies, while 610 research initiatives are actively recruiting candidates for Mycophenolate Mofetil/Mycophenolic Acid treatments."

Answered by AI

What kinds of ailments is Mycophenolate Mofetil/Mycophenolic Acid typically prescribed for?

"Mycophenolate Mofetil/Mycophenolic Acid is typically prescribed to address scalp structure, although it has seen success in treating a range of conditions including thyroiditis, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Are individuals over 70 ineligible for this medical experiment?

"As outlined in the inclusion criteria for this medical trial, individuals must be aged 18 or over and no older than 75."

Answered by AI

Has Mycophenolate Mofetil/Mycophenolic Acid been utilized for research in the past?

"Currently, there are 610 trials actively researching Mycophenolate Mofetil/Mycophenolic Acid with 143 of them in their final phase. Many of these can be found in Philadelphia, Pennsylvania though much further afield one will find an additional 22,264 studies dedicated to this medication."

Answered by AI

Is there a way for me to be involved in this medical experiment?

"Potential participants must have lupus nephritis and be between 18 to 75 years of age in order to take part in this trial. The total number of patients wanted for the study is 126."

Answered by AI

Are there several centers in the US administering this research?

"Currently, the trial is administered through 7 locations across America. The clinics are located in La Jolla, Palo Alto and Columbus as well as several other cities. To reduce travel costs associated with participation, it's recommended to select a clinic closest to you."

Answered by AI

How many participants have been recruited for this medical trial?

"This particular research study is not currently recruiting new patients. It was initially published on November 13th 2015 and most recently updated on the 14th of November 20202. Unfortuantely, this trial has concluded its recruitment period but there are 39 other trials for lupus nephritis and 610 studies involving Mycophenolate Mofetil/Mycophenolic Acid that are still enrolling participants."

Answered by AI
Recent research and studies
Pediatric NephrologyJournal
Response to Majeranowski
Dossier, Claire, and Julien Hogan. 2021. “Response to Majeranowski”. Pediatric Nephrology. Springer Science and Business Media LLC. doi:10.1007/s00467-021-04982-4.
Annals of the Rheumatic DiseasesJournal
B-cell Depletion with Obinutuzumab for the Treatment of Proliferative Lupus Nephritis: A Randomised, Double-blind, Placebo-controlled Trial
Furie, Richard A, Gustavo Aroca, Matthew D Cascino, Jay P Garg, Brad H Rovin, Analia Alvarez, Hilda Fragoso-Loyo, et al.. 2021. “B-cell Depletion with Obinutuzumab for the Treatment of Proliferative Lupus Nephritis: A Randomised, Double-blind, Placebo-controlled Trial”. Annals of the Rheumatic Diseases. BMJ. doi:10.1136/annrheumdis-2021-220920.
Annals of the Rheumatic DiseasesJournal
B-cell Depletion with Obinutuzumab for the Treatment of Proliferative Lupus Nephritis: A Randomised, Double-blind, Placebo-controlled Trial
Furie, Richard A, Gustavo Aroca, Matthew D Cascino, Jay P Garg, Brad H Rovin, Analia Alvarez, Hilda Fragoso-Loyo, et al.. 2021. “B-cell Depletion with Obinutuzumab for the Treatment of Proliferative Lupus Nephritis: A Randomised, Double-blind, Placebo-controlled Trial”. Annals of the Rheumatic Diseases. BMJ. doi:10.1136/annrheumdis-2021-220920.
clinicaltrials.govStudy
A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)
2015. "A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02550652.
~13 spots leftby Apr 2025
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