Clinical Trials Logo
  1. Home
  2. Lupus Nephritis
  3. NCT04564339
  4. Details
NCT04564339 Clinical Trial

Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

Lupus Nephritis Clinical Trial

— SANCTUARY  

Official title:
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04564339
Other study ID # ALXN1210-NEPH-202
Secondary ID 2020-001537-13
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 11, 2020
Est. completion date October 31, 2026

Study information
Verified date November 2023
Source Alexion Pharmaceuticals, Inc.
Contact Alexion Pharmaceuticals, Inc.
Phone 855-752-2356
Email clinicaltrials@alexion.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN (LN Cohort) or IgAN (IgAN Cohort).

Description:

This study consists of a 6-week Screening Period, 26-week Initial Evaluation Period, a 24-week Extension Period, and a 36-week post-treatment Follow-up Period.

Read more »

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ravulizumab
Dosages (loading and maintenance) will be based on the participant's body weight.
• Placebo
Dosages (loading and maintenance) will be based on the participant's body weight.
Other:
• Background Therapy
Participants will receive background therapy consistent with the standard of care.
See more »

Sponsors (1)
Lead Sponsor Collaborator
Alexion Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Singapore,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 26 Assessed Using 24-hour Urine Collections Baseline, Week 26
Secondary Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 50 Assessed Using 24-hour Urine Collections Baseline, Week 50
Secondary Both Cohorts: Change In Estimated Glomerular Filtration Rate (eGFR) From Baseline At Week 26 And Week 50 Baseline, Week 26, Week 50
Secondary LN Cohort: Percentage Of Participants Meeting The Criteria For Complete Renal Response Complete renal response will be determined by assessing proteinuria on 24-hour urine collections, eGFR levels, and no treatment failure. Week 26 and Week 50
Secondary LN Cohort: Percentage Of Participants Meeting The Criteria For Partial Renal Response Partial renal response will be determined by assessing proteinuria on 24-hour urine collections, eGFR levels, and no treatment failure. Week 26 and Week 50
Secondary LN Cohort: Time To Urine Protein To Creatinine Ratio < 0.5 g/g Baseline through Week 50
Secondary LN Cohort: Percentage Of Participants Achieving Corticosteroid Taper To 7.5 mg/day Week 14, Week 26, and Week 50
Secondary LN Cohort: Percentage Of Participants With Renal Flare Baseline through Week 50
Secondary LN Cohort: Percentage Of Participants With Extrarenal Systemic Lupus Erythematosus Flare Baseline through Week 50
Secondary IgAN Cohort: Percentage Of Participants Meeting The Criteria For Partial Remission Partial remission will be determined by assessing proteinuria on 24-hour urine collections. Week 26 and Week 50
See also
  Status Clinical Trial Phase
Recruiting NCT02936375 - The Iguratimod Effect on Lupus Nephritis (IGeLU) Phase 2
Completed NCT03597464 - Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin Phase 3
Recruiting NCT01226147 - Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis Phase 2
Completed NCT01206569 - Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis Phase 4
Active, not recruiting NCT00569101 - A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis Phase 2
Terminated NCT00368264 - TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL ) Phase 2/Phase 3
Completed NCT00371319 - Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis Phase 4
Completed NCT00298506 - Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V) N/A
Completed NCT00094380 - Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077) Phase 1/Phase 2
Terminated NCT04376827 - A Study of Guselkumab in Participants With Active Lupus Nephritis Phase 2
Completed NCT03610516 - Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis. Phase 2
Recruiting NCT03526042 - Angiotensin-II Receptor Antibodies Blockade With Losartan in Patients With Lupus Nephritis N/A
Withdrawn NCT03859570 - Pentoxifylline in Lupus Nephritis Phase 4
Completed NCT03664908 - Detection of Anti-glomerular Basement Membrane Antibodies (Anti-GBM): a Promising Biomarker for Lupus Nephritis (LN)? N/A
Completed NCT01085097 - A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis Phase 2
Active, not recruiting NCT05704088 - SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Lupus Nephritis Patients Phase 4
Not yet recruiting NCT06429800 - A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Lupus Nephritis Phase 1
Recruiting NCT02226341 - ACTHar in the Treatment of Lupus Nephritis Phase 4
Recruiting NCT02453997 - Mycophenolic Acid Pharmacokinetics and Pharmacogenomics in Lupus Nephritis N/A
Completed NCT01470183 - Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients N/A