An adaptive seamless randomized, double-blind, placebocontrolled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients
This Study is
No Longer Enrolling
Each study subject will be randomized to receive either study drug or a placebo for 6 months. Neither the subject nor the study staff will know which treatment was given until after the study has finished. Study subjects will be monitored every 2 weeks for the first month, then less frequently as the study progresses. The total length of the study is about 8 months.
MoreAdult
Males and females who are 18 years of age or older, and have had a biopsy-verified IgA nephropathy within the last three years.
Inclusion criteria: -The eGFR needs to be > or = to 30 mL/minute. Patients not eligible for the study include: -Transplant patients -Chronic infections with hepatitis B or C, or HIV -Female patients who are pregnant or breastfeeding
II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
Treatment
Renal Research Center
University of Colorado Hospital
Protocol Number: 19-2819
More information available at ClinicalTrials.gov: NCT03373461
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