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A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
NotableEnrollment reopenedEnrollment increased: 448 → 540 participants · Trial sites expanded: 155 → 161 locations · Eligibility criteria expanded, about 13 words · 2 moreShow 5 more changesShow less
Enrollment increased: 448 → 540 participants
Trial sites expanded: 155 → 161 locations
Eligibility criteria expanded, about 13 words
Secondary endpoints: details revised at 1 of 3 entries
Study description expanded, about 8 words
MinorSite details revised at 3 of 155 sitesv27
MinorSite details revised at 1 of 155 sitesv26
MinorTrial status changed: Recruiting → Active, Not RecruitingEnrollment reduced: 540 → 448 participants · Trial sites reduced: 161 → 155 locationsv25Show 2 more changesShow less
Enrollment reduced: 540 → 448 participants
Trial sites reduced: 161 → 155 locations
NotablePrimary and study completion moved earlier from Oct 25, 2032 to Dec 4, 2030Site details revised at 8 of 161 sitesv24Show 1 more changeShow less
Site details revised at 8 of 161 sites
Show 22 earlier versionsHide 22 earlier versions
MinorSite details revised at 2 of 161 sitesv23
MinorSite details revised at 9 of 161 sitesv22
MinorStudy sites: 146 to 161Primary and study completion dates: Nov 11, 2032 to Oct 25, 2032v21Show 1 more changeShow less
Primary and study completion dates: Nov 11, 2032 to Oct 25, 2032
MinorStudy sites: 141 to 146v20
MinorStudy sites: 139 to 141v19
MinorStudy sites: 133 to 139v18
MinorEnrollment target: 500 to 540Study sites: 121 to 133 · Primary and study completion dates: Oct 28, 2032 to Nov 11, 2032v17Show 2 more changesShow less
Study sites: 121 to 133
Primary and study completion dates: Oct 28, 2032 to Nov 11, 2032
MinorStudy sites: 107 to 121Primary and study completion dates: Oct 22, 2032 to Oct 28, 2032v16Show 1 more changeShow less
Primary and study completion dates: Oct 22, 2032 to Oct 28, 2032
MinorStudy sites: 99 to 107v15
MinorStudy sites: 95 to 99v14
MinorStudy sites: 86 to 95Primary and study completion dates: May 31, 2032 to Oct 22, 2032v13Show 1 more changeShow less
Primary and study completion dates: May 31, 2032 to Oct 22, 2032
MinorStudy sites: 78 to 86v12
MinorEnrollment target: 410 to 500Study sites: 73 to 78v11Show 1 more changeShow less
Study sites: 73 to 78
MinorStudy sites: 59 to 73v10
MinorStudy sites: 50 to 59v9
MinorStudy sites: 46 to 50v8
MinorStudy sites: 41 to 46v7
NotablePrimary and study completion dates: Jan 4, 2029 to May 31, 2032Study sites: 29 to 41v6Show 1 more changeShow less
Study sites: 29 to 41
MinorStudy sites: 2 to 29v5
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 2 · Start date changed from estimate of Sep 28, 2021 to Sep 20, 2021v4Show 2 more changesShow less
Study sites: 0 to 2
Start date changed from estimate of Sep 28, 2021 to Sep 20, 2021
NotableStart date: Aug 27, 2021 to Sep 28, 2021Primary endpoints revised (6) · Primary and study completion dates: Dec 5, 2028 to Jan 4, 2029 · Eligibility criteria expanded, about 8 words · 2 morev3Show 5 more changesShow less
Primary endpoints revised (6)
Primary and study completion dates: Dec 5, 2028 to Jan 4, 2029
NotablePrimary and study completion dates: May 26, 2028 to Dec 5, 2028Start date: Feb 17, 2021 to Aug 27, 2021v2Show 1 more changeShow less
Start date: Feb 17, 2021 to Aug 27, 2021
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.