Back to Results

An adaptive seamless randomized, double-blind, placebocontrolled, dose ranging study to investigate the efficacy and safety of LNP023 in primary IgA nephropathy patients

Study category: Kidney Disease & Hypertension

Is this Study for You?

Let's Get Started!

Description

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.

Details
Age

Adult

Eligibility

Males and females who are 18 years of age or older, and have had a biopsy-verified IgA nephropathy within the last three years.

Detailed Eligibility: 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

Phase

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.

Type of Study

Treatment

Locations

Renal Research Center
University of Colorado Hospital

Principal Investigator
Judith Blaine

Judith Blaine

Study ID

Protocol Number: 19-2819

ClinicalTrials.gov: NCT03373461

Is this Study for You?

Let's Get Started!

Not finding the right Study for you? Join ResearchMatch, a nation-wide registry connecting volunteers and researchers