Clinical Trial: The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 N

Brief Summary: 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).

Detailed Summary:

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.


Sponsor: Pharmalink AB

Current Primary Outcome: Change from baseline in urine protein creatinine ratio [ Time Frame: 9 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in urine albumin creatinine ratio [ Time Frame: 9 months ]
  • Change from baseline in 24 hour albuminuria [ Time Frame: 9 months ]
  • Change from baseline in estimated GFR [ Time Frame: 9 months ]


Original Secondary Outcome: Same as current

Information By: Pharmalink AB

Dates:
Date Received: July 25, 2012
Date Started: December 2012
Date Completion:
Last Updated: September 23, 2015
Last Verified: September 2015