A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With AC… (NCT03459443) | Clinical Trial Compass
TerminatedPhase 2
A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471
Stopped: The reason for terminating study early was inconclusive efficacy results. No safety findings were identified.
United States22 participantsStarted 2018-06-20
Plain-language summary
The primary purpose of this study was to evaluate the efficacy of 12 months of oral ACH-0144471 (also known as danicopan and ALXN2040) in participants with C3G or IC-MPGN based on histologic scoring and proteinuria.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. At least 12 years of age
✓. Completion of the ACH471-201 clinical study OR diagnosed with biopsy-confirmed primary C3G or IC-MPGN
✓. If a pre-treatment biopsy is obtained, or if a historical biopsy is available for review, it must have no more than 50% global fibrosis and no more than 50% of glomeruli with cellular crescents
✓. Clinical evidence of ongoing disease based on significant proteinuria (defined as ≥500 mg/day of protein in a 24-hour urine) attributable to C3G disease or IC-MPGN in the opinion of the principal investigator (PI), and present prior to study entry and confirmed during Screening
✓. If on corticosteroids, anti-hypertensive medications, anti-proteinuric medications (for example, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers), or mycophenolate mofetil, must be on a stable dose for at least 2 weeks prior to screening
✓. Female participants must use an acceptable method birth control to prevent pregnancy during the clinical study and for 30 days after the last dose of study medication
✓. Male participants must use highly effective birth control with a female partner to prevent pregnancy during the clinical study and for 90 days after the last dose of study medication
✓. Must be up-to-date on routine vaccinations, or willing to be brought up-to-date, based on local guidelines
Exclusion criteria
✕. Have a history of a major organ transplant (for example, heart, lung, kidney, or liver) or hematopoietic stem cell/marrow transplant
What they're measuring
1
Change From Baseline In Composite Biopsy Score At End Of Initial 12-Month Treatment Period
Timeframe: Baseline, end of initial 12-Month Treatment Period
2
Participants With Reduction In Proteinuria At End Of Initial 12-Month Treatment Period
Timeframe: Baseline, end of initial 12-Month Treatment Period
✕. Have a history or presence of any clinically relevant co-morbidities that would make the participant inappropriate for the study (for example, a comorbidity that is likely to result in deterioration of the participant's condition, affect the participant's safety during the study, or confound the results of the study), in the opinion of the PI
✕. Have an eGFR \<30 milliliter/minute/1.73 m\^2 at the time of screening or at any time over the preceding 4 weeks
✕. Is a renal transplant recipient or receiving renal replacement therapy
✕. Have other renal diseases that would interfere with the interpretation of the study
✕. Have evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which C3G or IC-MPGN is secondary
✕. Have been diagnosed with or show evidence of hepatobiliary cholestasis
✕. Females who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of ACH-0144471 administration or participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of ACH-0144471 administration