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A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients

Study

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Description

Each patient will go through a screening visit, followed by a run in period of 14 to approximately 90 days. Thereafter, eligible participants will be randomized in a 1:1 ratio to either LNP023 200mg or matching placebo b.i.d. for a 24 month treatment period.

Details
Age

Adult

Eligibility

Male and female patients ≥ 18 years of age with an eGFR level and biopsy-confirmed IgA nephropathy.

Detailed Eligibility: Inclusion Criteria: -Biopsy as follows:  For patients eGFR* ≥ 45ml/min/1.73m2, a qualifying biopsy performed within the last 5 years is required  For patients with eGFR* 30 to <45ml/min/1.73m2, a qualifying biopsy performed within 2 years with < 50% tubulointerstitial fibrosis is required  For patients with eGFR* 20 to <30ml/min/1.73m2, a qualifying biopsy performed at any time. In all cases, if a historical biopsy is not available, one may be performed during screening. -Proteinuria due to primary diagnosis of IgA nephropathy as assessed at screening by UPCR ≥1 g/g (113 mg/mmol) sampled from FMV or 24h urine collection, as well as at the completion of the run-in period by UPCR ≥1 g/g (113 mg/mmol) calculated as the mean of two 24h urine collections obtained within 14 days of each other at baseline. -Vaccinations: Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae. -All patients must have been on supportive care including stable dose regimen of ACEi or ARB at either the locally approved maximal daily dose or the maximally tolerated dose (per investigators’ judgment) for at least 90 days before first study drug administration. In addition, if patients are taking diuretics or other antihypertensive therapy, the doses should also be stabilized for at least 90 days prior to the first dosing of study treatment. Exclusion Criteria: -Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, and inflammatory bowel disease, familial mediterranean fever, etc. -Sitting office SBP >140 mmHg or DBP >90 mmHg at the randomization visit -Patients previously treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, hydroxychloroquine, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids exposure (>10 mg/d prednisone/prednisolone equivalent) within 90 days (or 180 days for rituximab) prior to first study drug administration.

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Treatment

Locations

Renal Research Center
University of Colorado Hospital

Principal Investigator
Judith Blaine

Judith Blaine

Study ID

Protocol Number: 20-3010

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