Trial record 1 of 2 for:
CLNP023A2301
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
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| ClinicalTrials.gov Identifier: NCT04557462 |
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Recruitment Status :
Recruiting
First Posted : September 21, 2020
Last Update Posted : April 15, 2024
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Primary IgA Nephropathy | Drug: LNP023 | Phase 3 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
This is an open-label, non-randomized, multicenter roll-over extension program (REP) to:
- CLNP023X2203, a Phase II trial investigating the dose ranging effects of LNP023 on efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability in primary IgAN patients, and
- CLNP023A2301, a Phase III trial, investigating the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of LNP023 in patients with primary IgAN.
Subjects completing the CLNP023X2203 and CLNP023A2301 trials on study drug, who want to continue treatment and who meet the inclusion/exclusion requirements of the roll over extension program, will have the opportunity to receive iptacopan until:
- 3 years from LPFV of this study CLNP023A2002B, or
- the participant no longer derives benefit from iptacopan according to the Investigator, or
- the benefit-risk profile of the product in IgAN is no longer positive, or
- initiation of maintenance hemodialysis, kidney transplantation or eGFR < 15 mL/min/1.73m2 , or
- the product becomes commercially available in a specific country following product launch and subsequent reimbursement for IgAN, where applicable, or
- if a marketing application or reimbursement of an investigational product is rejected/not pursued in a region/country for the indication under study or which ever is sooner
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan in Adult Participants With Primary IgA Nephropathy Who Have Completed Study CLNP023X2203 or CLNP023A2301 |
| Actual Study Start Date : | September 20, 2021 |
| Estimated Primary Completion Date : | May 31, 2032 |
| Estimated Study Completion Date : | May 31, 2032 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Diseases
| Arm | Intervention/treatment |
|---|---|
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Experimental: LNP023
All participants are receiving 200 mg b.i.d
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Drug: LNP023
Capsule 200 mg (b.i.d.) taken orally twice a day
Other Name: iptacopan |
Primary Outcome Measures :
- Number and percentage of participants with serious adverse event [ Time Frame: Date of first administration of (Day 1) to 7 days after the date of the last actual administration of study treatment ]Summary statistics on serious adverse events
- Number and percentage of participants with adverse event [ Time Frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment ]Summary statistics on adverse events
- Number and percentage of participants with adverse events of special interest [ Time Frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual adminstration of study treatment ]Summary statistics on adverse events of special interest
- Number and percentage of participants with abnormalities in vital signs [ Time Frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment ]Summary statistics on abnormalities in vital sign parameters
- Number and percentage of participants with abnormalities in ECG [ Time Frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment ]Summary statistics in abnormalities in ECG parameters
- Number and percentage of participants with abnormalities in clinical laboratory evaluations [ Time Frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment ]Summary statistics on abnormalities in clinical laboratory evaluations
Secondary Outcome Measures :
- Annualized total eGFR slope [ Time Frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter ]Annualized rate of renal disease progression as measured by mean eGFR slope at post baseline visits
- Change from baseline in eGFR [ Time Frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter ]Average change from baseline in eGFR at post-baseline visits
- Log transformed ratio to baseline in UPCR, UACR [ Time Frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter ]Log transformed ratio to baseline in UPCR, UACR at post-baseline visits. The log transformation refers to the natural log (base on e)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- For LNP023X2203, participants must have completed part 1 or part 2 of the trial. For LNP023A2301, participants must have completed the entire core trial defined as the full 24 month treatment period.
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eGFR* ≥ 20 ml/min/1.73m2
*eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)
- Per investigator's clinical judgement, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d.
- Prior Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations.
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All participants must be on supportive care regimen of ACEi or ARB* as per KDIGO guidelines.
- participants who are not taking KDIGO guideline doses because they have documented allergies or intolerance to ACEi and ARB are eligible for the study
Exclusion Criteria:
- participants who screen or baseline failed in the CLNP023X2203 Part 1 or Part 2, or CLNP023A2301 studies or who prematurely withdrew from either study for any reason.
- Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with LNP023.
- Current (within 4 weeks of study drug administration in the REP) acute kidney injury (AKI)
- Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months.
- Participants treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus and/or systemic corticosteroids exposure (>7.5 mg/d prednisone/prednisolone equivalent) within 5 half-lives of respective medication or 90 days prior to first study drug administration, whichever is shorter. Rituximab requires 180 days wash out.
- Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 30 days whichever is longer.
- History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.
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): NCT04557462
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | novartis.email@novartis.com | |
| Contact: Novartis Pharmaceuticals | +41613241111 |
Locations
Show 86 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04557462 |
| Other Study ID Numbers: |
CLNP023A2002B 2020-002200-40 ( EudraCT Number ) |
| First Posted: | September 21, 2020 Key Record Dates |
| Last Update Posted: | April 15, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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Immunoglobulin A nephropathy Primary IgA nephropathy IgAN chronic kidney disease glomerulonephritis |
complement alternative pathway eGFR UPCR UACR LNP023 |
Additional relevant MeSH terms:
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Kidney Diseases Glomerulonephritis, IGA Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Male Urogenital Diseases Glomerulonephritis Nephritis Autoimmune Diseases Immune System Diseases |