Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy (Nefigard)
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|ClinicalTrials.gov Identifier: NCT03643965|
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Primary IgA Nephropathy||Drug: Nefecon Drug: Placebo oral capsule||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd)|
|Actual Study Start Date :||September 5, 2018|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||December 2024|
Nefecon 16 mg once daily by mouth for 9 months.
Nefecon 16 mg for daily administration by mouth for 9 months.
Other Name: Budesonide modified released capsule
Placebo Comparator: Placebo oral capsule
Placebo oral capsule once daily by mouth for 9 months.
Drug: Placebo oral capsule
Placebo capsules for daily administration by mouth for 9 months.
Other Name: Placebo
- Change in Proteinuria, measured as Urine Protein to creatinine ratio (UPCR). [ Time Frame: 9 months ]The primary outcome measure is UPCR (based on 24-hour urine collections) at 9 months following the first dose of study drug compared to baseline
- Events based on renal function measured as estimated glomerular filtration rate (eGFR) [ Time Frame: Up to 6 years ]Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula
- The incidence of treatment-emergent adverse events. [ Time Frame: From enrollment and up to 6 years ]
- Renal function [ Time Frame: Up to 6 years ]Renal function measured as eGFR using the CKD-EPI formula
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643965
|Contact: Medpace Research, Incemail@example.com|
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