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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04564339
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : March 16, 2022
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Brief 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).

Condition or disease Intervention/treatment Phase
Lupus Nephritis Immunoglobulin A Nephropathy Drug: Ravulizumab Drug: Placebo Other: Background Therapy Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants, all investigative site personnel, and any Alexion employee, or designee, directly associated with the conduct of the study will be blinded to participant treatment assignments during the 26-week Initial Evaluation Period. Both the participants and the investigative site personnel will remain blinded for the remaining 24-week Extension Period.
Primary Purpose: Treatment
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)
Actual Study Start Date : December 11, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Ravulizumab

Arm Intervention/treatment
Experimental: Ravulizumab: LN Cohort
Eligible participants will receive ravulizumab IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.
Drug: Ravulizumab
Dosages (loading and maintenance) will be based on the participant's body weight.
Other Name: Ultomiris

Other: Background Therapy
Participants will receive background therapy consistent with the standard of care.

Placebo Comparator: Placebo: LN Cohort
Eligible participants will receive placebo IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.
Drug: 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.

Experimental: Ravulizumab: IgAN Cohort
Eligible participants will receive ravulizumab IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.
Drug: Ravulizumab
Dosages (loading and maintenance) will be based on the participant's body weight.
Other Name: Ultomiris

Other: Background Therapy
Participants will receive background therapy consistent with the standard of care.

Placebo Comparator: Placebo: IgAN Cohort
Eligible participants will receive placebo IV infusion in combination with background therapy during the Initial Evaluation Period (26 weeks) and will switch to ravulizumab for the Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.
Drug: Ravulizumab
Dosages (loading and maintenance) will be based on the participant's body weight.
Other Name: Ultomiris

Drug: 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.




Primary Outcome Measures :
  1. Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 26 Assessed Using 24-hour Urine Collections [ Time Frame: Baseline, Week 26 ]

Secondary Outcome Measures :
  1. Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 50 Assessed Using 24-hour Urine Collections [ Time Frame: Baseline, Week 50 ]
  2. Both Cohorts: Change In Estimated Glomerular Filtration Rate (eGFR) From Baseline At Week 26 And Week 50 [ Time Frame: Baseline, Week 26, Week 50 ]
  3. LN Cohort: Percentage Of Participants Meeting The Criteria For Complete Renal Response [ Time Frame: Week 26 and Week 50 ]
    Complete renal response will be determined by assessing proteinuria on 24-hour urine collections, eGFR levels, and no treatment failure.

  4. LN Cohort: Percentage Of Participants Meeting The Criteria For Partial Renal Response [ Time Frame: Week 26 and Week 50 ]
    Partial renal response will be determined by assessing proteinuria on 24-hour urine collections, eGFR levels, and no treatment failure.

  5. LN Cohort: Time To Urine Protein To Creatinine Ratio < 0.5 g/g [ Time Frame: Baseline through Week 50 ]
  6. LN Cohort: Percentage Of Participants Achieving Corticosteroid Taper To 7.5 mg/day [ Time Frame: Week 14, Week 26, and Week 50 ]
  7. LN Cohort: Percentage Of Participants With Renal Flare [ Time Frame: Baseline through Week 50 ]
  8. LN Cohort: Percentage Of Participants With Extrarenal Systemic Lupus Erythematosus Flare [ Time Frame: Baseline through Week 50 ]
  9. IgAN Cohort: Percentage Of Participants Meeting The Criteria For Partial Remission [ Time Frame: Week 26 and Week 50 ]
    Partial remission will be determined by assessing proteinuria on 24-hour urine collections.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Common to both disease cohorts:

  • Proteinuria ≥1 (gram [g]/day or g/g)
  • Vaccinated against meningococcal infection
  • Vaccinated for Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae according to national/local regulatory requirements

For LN cohort:

  • Diagnosis of active focal or diffuse proliferative LN Class III or IV
  • Clinically active LN, requiring/receiving immunosuppression induction treatment

For IgAN cohort:

  • Diagnosis of primary IgAN
  • Compliance with stable and optimal dose of renin-angiotensin system inhibitor treatment for ≥ 3 months

Exclusion Criteria:

Common to both disease cohorts:

  • eGFR < 30 milliliters/minute/1.73 meters squared
  • Previously received a complement inhibitor (for example, eculizumab)
  • Concomitant significant renal disease other than LN or IgAN
  • History of other solid organ or bone marrow transplant
  • Uncontrolled hypertension

For IgAN cohort:

  • Diagnosis of rapid progressive glomerulonephritis
  • Prednisone or prednisone equivalent > 20 milligram (mg) per day for > 14 consecutive days or any other immunosuppression within 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564339


Contacts
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Contact: Alexion Pharmaceuticals, Inc. 855-752-2356 clinicaltrials@alexion.com

Locations
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Sponsors and Collaborators
Alexion Pharmaceuticals
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Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04564339    
Other Study ID Numbers: ALXN1210-NEPH-202
2020-001537-13 ( EudraCT Number )
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: March 16, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexion Pharmaceuticals:
glomerulonephritis
IGA
lupus nephritis
complement C5
Additional relevant MeSH terms:
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Kidney Diseases
Nephritis
Lupus Nephritis
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Ravulizumab
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs