Primary IgA Nephropathy Clinical Trial
Official title:
A Multicentre, Interventional Treatment, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in Primary IgA Nephropathy Patients at Risk of End-stage Renal Disease
The objective of the study is to evaluate efficacy and safety of two different doses of NEFECON in the treatment of patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease, under rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor I blocker (ARB).
NEFECON is an add-on treatment to other medications for nephropathy symptoms and kidney
function, including ACEI and/or ARBs. Rigorous blood pressure control will be achieved over
a 6-month Run-in Phase in which ACEI and/or ARB will be dosed to target a blood pressure of
<130/80 mm Hg and UPCR <0.5 g/g. Patients who complete the Run-in Phase, and despite
optimized ACEI and/or ARB therapy, have a UPCR ≥0.5 g/g OR urine protein ≥0.75 g/24hr will
be eligible for randomization and entry into the treatment phase of the trial. Patients will
remain on their ACEI and/or ARB dosing regimen for the duration of the trial.
Patients entering the treatment phase will be administered NEFECON (8 mg/day OR 16 mg/day)
OR placebo for a phase of 9 months. A 3-month follow-up phase will follow on from the
treatment phase, of which the first 2 weeks will be used to taper the dose of those patients
that received 16 mg/day dosing to 8 mg/day, with the placebo and 8 mg/day groups receiving
placebo to retain blinding.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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