Pharmalink NEF-203
Research type
Research Study
Full title
An observational follow-up study of patients with Primary IgA Nephropathy treated with Nefecon® or Placebo in study Nef-202
IRAS ID
226156
Contact name
Alan Jardine
Contact email
Sponsor organisation
Pharmalink AB
Duration of Study in the UK
4 years, 3 months, 31 days
Research summary
The purpose of the Nef-203 Study is to learn more about the long-term effects of Nefecon® on Proteinuria (protein in the urine) and other variables, in patients with primary IgA nephropathy (IgAN). IgAN is an immune disease affecting kidney function. Patients have previously taken part in the Nefigan study, Nef-202, “A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end stage renal disease”. The Nef-202 study included a 6-month run in period, 9-month treatment period and a 3-month follow up period.
In the analysis of the data from the Nef-202 study, the levels of proteinuria were significantly lower in patients treated with Nefecon compared to placebo. Proteinuria is an indicator of that the kidneys are not working sufficiently.
Patients that were treated with at least two doses of Nefecon or placebo in the Nef-202 study are eligible to take part in this follow up study (Nef-203). Up to 149 subjects may take part, throughout Europe. Follow up will be from the end of the Nef-202 study until 2021. Patients who participate will provide consent for the review of their medical records, and collection of data about the progression of their disease, blood tests, and important medical events. Participants will not take any study medication, or have any procedures over and above the standard medical care for their condition.REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0265
Date of REC Opinion
8 Jun 2017
REC opinion
Further Information Favourable Opinion