Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transpl… (NCT03832114) | Clinical Trial Compass
CompletedPhase 2
Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted
United States, France, Germany27 participantsStarted 2019-02-20
Plain-language 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 transplant and have C3G recurrence (Cohort B).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Cohort A: Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR)