Status:
COMPLETED
Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Glomerulonephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study is an open-label, two cohort non-randomized study evaluating the efficacy, safety, and pharmacokinetics of LNP023 in patients with C3G (Cohort A) and patients who have undergone kidney trans...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Cohort A and B:
- Written informed consent must be obtained before any assessment is performed
- Male and female patients between the ages of 18 to 65 (inclusive) at screening
- C3G patients wit proteinuria
- Able to communicate well with the investigator, to understand and comply with the requirements of the study
- At screening and baseline visits, patients must weigh at least 35 kg
- Supine vital signs should be within the following ranges :
- oral body temperature between 35.0-37.5 °C systolic blood pressure, 80-170 mm Hg diastolic blood pressure, 50-105 mm Hg pulse rate, 45 - 100 bpm
- .
- Inclusion Criteria for Cohort A:
- Estimated GFR (using the CKD-EPI formula) or measured GFR ≥30 mL/min per 1.73 m2 for patients on a maximum recommended or maximum tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
- UPCR ≥ 100 mg/mmol (equivalent to ≥ 1 g/24h total urinary protein excretion)
- Prior to entry, all patients must have been on supportive care including a maximally tolerated dose of ACEi or ARB for at least 30 days.
- Inclusion Criteria for Cohort B:
- No histological/laboratory/clinical signs of allorejection
- If applicable, induction treatment after allotransplantation needs to be completed \>30 days before inclusion.
- Transplantation of a kidney allograft \>90 days before inclusion
- Patients need to be on a stable dose of immunosuppressive regimen prior to inclusion. Any approved treatments are allowed for this purpose.
- Exclusion Criteria for Cohort A and B:
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of randomization, or within 30 days, whichever is longer; or longer if required by local regulations
- A history of clinically significant ECG abnormalities,
- Known family history or known presence of long QT syndrome or Torsades de Pointes
- Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of the study
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- Women of child bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of investigational drug.
- History of immunodeficiency diseases, or a positive HIV test result.
- Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV).
- Patients who cannot receive vaccinations against N. meningitidis, S. pneumoniae, or H. influenzae
Exclusion
Key Trial Info
Start Date :
February 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03832114
Start Date
February 20 2019
End Date
April 23 2021
Last Update
January 30 2024
Active Locations (9)
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1
Novartis Investigative Site
Iowa City, Iowa, United States, 52242
2
Novartis Investigative Site
Montpellier, France, 34295
3
Novartis Investigative Site
Paris, France, 75015
4
Novartis Investigative Site
Essen, Germany, 45147