Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy (Nefigard)
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|ClinicalTrials.gov Identifier: NCT03643965|
Recruitment Status : Active, not recruiting
First Posted : August 23, 2018
Last Update Posted : August 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Primary IgA Nephropathy||Drug: Nefecon Drug: Placebo oral capsule||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||365 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 :||February 2023|
|Estimated Study Completion Date :||February 2023|
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
- Renal function measured as estimated glomerular filtration rate (eGFR) [ Time Frame: Up to 2 years ]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 2 years ]Adverse event data collection
- Renal function [ Time Frame: Up to 2 years ]Renal function measured as eGFR using the CKD-EPI formula
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643965
|Study Director:||Krassimir Mitchev, MD||Calliditas AB|