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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2022 |
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Main ID: |
NCT03369236 |
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Date of registration:
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17/11/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Proof-of-Concept Study of Danicopan for 6 Months of Treatment in Participants With C3 Glomerulopathy (C3G)
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Scientific title:
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A Phase 2, Proof-of-Concept, Randomized, Double-Blinded, Placebo-Controlled Study of ACH-0144471 Treatment for 6 Months in Patients With C3 Glomerulopathy (C3G), With an Open-label Extension |
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Date of first enrolment:
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June 12, 2018 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03369236 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- Had biopsy-confirmed primary C3G
- Had clinical evidence of ongoing disease based on significant proteinuria,
attributable to C3G disease in the opinion of the Principal Investigator (PI), and
present prior to study entry and confirmed during Screening
- Was willing to comply with vaccination requirements.
Key Exclusion Criteria:
- Had a history or presence of any clinically relevant co-morbidities that would make
the participant inappropriate for the study
- Had ever received danicopan
- Had more than 50% fibrosis or more than 50% of glomeruli with cellular crescents on
the pre-treatment renal biopsy
- Had an estimated glomerular filtration rate <30 milliliters/minute/1.73 meters squared
at the time of screening or at any time over the preceding 4 weeks
- Was a renal transplant recipient or receiving renal replacement therapy
- Had a history of a major organ transplant or hematopoietic stem cell/marrow transplant
- Had evidence of monoclonal gammopathy of unclear significance, infections, malignancy,
autoimmune diseases, or other conditions to which C3G is secondary
- Had other renal diseases that would interfere with interpretation of the study
- Had been diagnosed with or showed evidence of hepatobiliary cholestasis
- Females who were pregnant, nursing, or planning to become pregnant during the study or
within 90 days of study drug administration
- Had a history of febrile illness, a body temperature >38°Celsius, or other evidence of
a clinically significant active infection, within 14 days prior to study drug
administration
- Had evidence of human immunodeficiency virus, hepatitis B infection, or active
hepatitis C infection at Screening
- Had laboratory abnormalities at screening that, in the opinion of the PI, would make
the participant inappropriate for the study
Age minimum:
17 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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C3 Glomerulonephritis
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Dense Deposit Disease
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C3 Glomerulopathy
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Intervention(s)
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Drug: Danicopan
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Drug: Placebo
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Primary Outcome(s)
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Change From Baseline In Composite Biopsy Score At Week 28
[Time Frame: Baseline, Week 28]
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Participants With Reduction In Proteinuria At Week 28
[Time Frame: Week 28]
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Secondary Outcome(s)
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Change From Baseline In Proteinuria At Week 28
[Time Frame: Baseline, Week 28]
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Change From Baseline In eGFR At Week 28
[Time Frame: Baseline, Week 28]
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Slope Of Estimated Glomerular Filtration Rate (eGFR) After Open-label Danicopan Treatment
[Time Frame: 12 months]
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Slope Of Estimated Glomerular Filtration Rate (eGFR) From Baseline To 6 Months
[Time Frame: 6 months]
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Participants With Significant Improvement In eGFR Relative To Baseline At Week 28
[Time Frame: Baseline, Week 28]
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Participants With Significant Improvement In eGFR Relative To Baseline At Week 52
[Time Frame: Baseline, Week 52]
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Percent Change From Baseline In Proteinuria At Week 28
[Time Frame: Baseline, Week 28]
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Secondary ID(s)
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2017-000663-33
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ACH471-204
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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