Trial · NCT04564339
Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
NCT04564339, Phase 2, Terminated, Alexion Pharmaceuticals, Inc.; results first posted 2026-01-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN). Trials, record NCT04564339. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04564339
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
- NCT number
- NCT04564339
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 123 participants, actual
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Conditions
- Lupus Nephritis, Immunoglobulin A Nephropathy
- Interventions
- Ravulizumab, Placebo, Background Therapy
- First posted
- 2020-09-25
- Last updated
- 2026-01-22
- Other registries' IDs
- eudract:2020-001537-13
- Results first posted
- 2026-01-22
- Limitations and caveats
- The LN cohort of the study was terminated early due to lack of efficacy.
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 26 Measured by Absolute Protein (Based on 24-hour Urine Collections) | Baseline, Week 26 | Proteinuria, the presence of excess proteins in the urine, was measured by absolute protein in grams/day derived from 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated a reduction in symptoms. |
| Primary | LN Cohort: Percentage Change From Baseline in Proteinuria at Week 26 Measured by Urine Protein to Creatinine Ratio (UPCR) (Based on 24-hour Urine Collections) | Baseline, Week 26 | Proteinuria, the presence of excess proteins in the urine, was measured by UPCR in grams/gram derived from 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated a reduction in symptoms. |
| Secondary | IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by Absolute Protein (Based on 24-hour Urine Collections) | Baseline, Week 50 | Proteinuria, the presence of excess proteins in the urine, was measured by absolute protein in grams/day derived from 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated a reduction in symptoms. |
| Secondary | LN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by UPCR (Based on 24-hour Urine Collections) | Baseline, Week 50 | Proteinuria, the presence of excess proteins in the urine, was measured by UPCR in grams/gram derived from 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated a reduction in symptoms. |
| Secondary | IgAN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections | Baseline to Week 26 and Week 50 | Proteinuria, the presence of excess proteins in the urine, was measured by absolute protein in grams/day derived from 24-hour urine collections obtained at designated timepoints. |
| Secondary | LN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections | Baseline to Week 26 and Week 50 | Proteinuria, the presence of excess proteins in the urine, was measured by UPCR in grams/gram derived from 24-hour urine collections obtained at designated timepoints. |
| Secondary | IgAN Cohort: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Baseline, Week 26 and Week 50 | Changes in kidney function were monitored using measurements of eGFR and calculated based on the Chronic Kidney Disease Epidemiology Collaboration formula. Results are reported in milliliters/minute/1.73 meters squared (mL/min/1.73 m\^2). Estimates of change from baseline are least-square means based on a mixed-effect model for repeated measures model that included change from baseline as the response variable, treatment as independent variable and adjusts for covariates of baseline and the stratification factor at randomization. An increase in eGFR in response to treatment indicated a reduction in symptoms. |
| Secondary | LN Cohort: Change From Baseline in eGFR at Week 26 and Week 50 | Baseline, Week 26 and Week 50 | Changes in kidney function were monitored using measurements of eGFR and calculated based on the Chronic Kidney Disease Epidemiology Collaboration formula. Results are reported in mL/min/1.73 m\^2. Estimates of change from baseline are least-square means based on a mixed-effect model for repeated measures model that included change from baseline as the response variable, treatment as independent variable and adjusts for covariates of baseline and the stratification factor at randomization. An increase in eGFR in response to treatment indicated a reduction in symptoms. |
| Secondary | IgAN Cohort: Change From Baseline in Serum Complement Component 3 (C3) and Complement Component 4 (C4) Concentrations at Week 26 and Week 50 | Baseline, Week 26 and Week 50 | |
| Secondary | LN Cohort: Change From Baseline in Serum C3 and C4 Concentrations at Week 26 and Week 50 | Baseline, Week 26 and Week 50 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 26 Measured by Absolute Protein (Based on 24-hour Urine Collections) | Baseline, Week 26 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | percentage change | GEOMETRIC_LEAST_SQUARES_MEAN |
| PRIMARY | LN Cohort: Percentage Change From Baseline in Proteinuria at Week 26 Measured by Urine Protein to Creatinine Ratio (UPCR) (Based on 24-hour Urine Collections) | Baseline, Week 26 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | percentage change | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by Absolute Protein (Based on 24-hour Urine Collections) | Baseline, Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | percentage change | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | LN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by UPCR (Based on 24-hour Urine Collections) | Baseline, Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | percentage change | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | IgAN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections | Baseline to Week 26 and Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | percentage of participants | NUMBER |
| SECONDARY | LN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections | Baseline to Week 26 and Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. | percentage of participants | NUMBER |
| SECONDARY | IgAN Cohort: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Baseline, Week 26 and Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | mL/min/1.73 m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | LN Cohort: Change From Baseline in eGFR at Week 26 and Week 50 | Baseline, Week 26 and Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | mL/min/1.73 m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | IgAN Cohort: Change From Baseline in Serum Complement Component 3 (C3) and Complement Component 4 (C4) Concentrations at Week 26 and Week 50 | Baseline, Week 26 and Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | grams/liter | MEAN |
| SECONDARY | LN Cohort: Change From Baseline in Serum C3 and C4 Concentrations at Week 26 and Week 50 | Baseline, Week 26 and Week 50 | FAS included all randomized participants who received at least 1 dose of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | grams/liter | LEAST_SQUARES_MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 26 Measured by Absolute Protein (Based on 24-hour Urine Collections) | IgAN Cohort: Ravulizumab | -41.9 | 95% Confidence Interval -50.2 to -32.0 | percentage change | |
| IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 26 Measured by Absolute Protein (Based on 24-hour Urine Collections) | IgAN Cohort: Placebo | -16.8 | 95% Confidence Interval -31.8 to 1.6 | percentage change | |
| LN Cohort: Percentage Change From Baseline in Proteinuria at Week 26 Measured by Urine Protein to Creatinine Ratio (UPCR) (Based on 24-hour Urine Collections) | LN Cohort: Ravulizumab | -69.7 | 95% Confidence Interval -79.9 to -54.5 | percentage change | |
| LN Cohort: Percentage Change From Baseline in Proteinuria at Week 26 Measured by Urine Protein to Creatinine Ratio (UPCR) (Based on 24-hour Urine Collections) | LN Cohort: Placebo | -67.0 | 95% Confidence Interval -80.8 to -43.1 | percentage change | |
| IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by Absolute Protein (Based on 24-hour Urine Collections) | IgAN Cohort - Ravulizumab | -44.8 | 95% Confidence Interval -55.1 to -32.1 | percentage change | |
| IgAN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by Absolute Protein (Based on 24-hour Urine Collections) | IgAN Cohort - Placebo | -45.1 | 95% Confidence Interval -58.0 to -28.4 | percentage change | |
| LN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by UPCR (Based on 24-hour Urine Collections) | LN Cohort: Ravulizumab | -77.1 | 95% Confidence Interval -86.0 to -62.4 | percentage change | |
| LN Cohort: Percentage Change From Baseline in Proteinuria at Week 50 Measured by UPCR (Based on 24-hour Urine Collections) | LN Cohort: Placebo | -75.0 | 95% Confidence Interval -87.2 to -51.2 | percentage change | |
| IgAN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections | IgAN Cohort: Ravulizumab | Week 26: >30% Reduction | 68.3 | 95% Confidence Interval 51.9 to 81.9 | percentage of participants |
| IgAN Cohort: Percentage of Participants With > 30% and > 50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline Assessed Using 24-hour Urine Collections | IgAN Cohort: Placebo | Week 26: >30% Reduction | 40.9 | 95% Confidence Interval 20.7 to 63.6 | percentage of participants |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Evaluation Period (26 Weeks) | STARTED | LN Cohort: Ravulizumab | 38 | |
| Initial Evaluation Period (26 Weeks) | STARTED | LN Cohort: Placebo | 19 | |
| Initial Evaluation Period (26 Weeks) | STARTED | IgAN Cohort: Ravulizumab | 43 | |
| Initial Evaluation Period (26 Weeks) | STARTED | IgAN Cohort: Placebo | 23 | |
| Initial Evaluation Period (26 Weeks) | Received at Least 1 Dose of Study Drug | LN Cohort: Ravulizumab | 38 | |
| Initial Evaluation Period (26 Weeks) | Received at Least 1 Dose of Study Drug | LN Cohort: Placebo | 19 | |
| Initial Evaluation Period (26 Weeks) | Received at Least 1 Dose of Study Drug | IgAN Cohort: Ravulizumab | 43 | |
| Initial Evaluation Period (26 Weeks) | Received at Least 1 Dose of Study Drug | IgAN Cohort: Placebo | 23 | |
| Initial Evaluation Period (26 Weeks) | COMPLETED | LN Cohort: Ravulizumab | 36 | |
| Initial Evaluation Period (26 Weeks) | COMPLETED | LN Cohort: Placebo | 18 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events960
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Initial Evaluation Period: LN Cohort - Ravulizumab | 2 | 38 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Initial Evaluation Period: LN Cohort - Placebo | 0 | 19 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Initial Evaluation Period: IgAN Cohort - Ravulizumab | 0 | 43 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Initial Evaluation Period: IgAN Cohort - Placebo | 0 | 23 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Extension Period: LN Cohort - Ravulizumab to Ravulizumab | 0 | 36 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Extension Period: LN Cohort - Placebo to Placebo | 0 | 18 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Extension Period: IgAN Cohort - Ravulizumab to Ravulizumab | 0 | 42 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Extension Period: IgAN Cohort - Placebo to Ravulizumab | 0 | 23 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Initial Evaluation Period: LN Cohort - Ravulizumab | 1 | 38 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Initial Evaluation Period: LN Cohort - Placebo | 1 | 19 | 1 |
1 to 10 of 960Source ClinicalTrials.gov
See all 960 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Initial Evaluation Period: LN Cohort - Ravulizumab | 0 | 38 |
| Total, all-cause mortality | Initial Evaluation Period: LN Cohort - Placebo | 0 | 19 |
| Total, all-cause mortality | Initial Evaluation Period: IgAN Cohort - Ravulizumab | 0 | 43 |
| Total, all-cause mortality | Initial Evaluation Period: IgAN Cohort - Placebo | 0 | 23 |
| Total, all-cause mortality | Extension Period: LN Cohort - Ravulizumab to Ravulizumab | 0 | 36 |
| Total, all-cause mortality | Extension Period: LN Cohort - Placebo to Placebo | 0 | 18 |
| Total, all-cause mortality | Extension Period: IgAN Cohort - Ravulizumab to Ravulizumab | 0 | 42 |
| Total, all-cause mortality | Extension Period: IgAN Cohort - Placebo to Ravulizumab | 0 | 23 |
| Total, other adverse events | Initial Evaluation Period: LN Cohort - Ravulizumab | 28 | 38 |
| Total, other adverse events | Initial Evaluation Period: LN Cohort - Placebo | 15 | 19 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04564339
GET https://conductscience.org/api/trials/v1/NCT04564339/results?page=2