The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease
NEFIGAN
A Multicentre, Interventional Treatment, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in Primary IgA Nephropathy Patients at Risk of End-stage Renal Disease
2 other identifiers
interventional
150
10 countries
58
Brief Summary
The objective of the study is to evaluate efficacy and safety of two different doses of NEFECON in the treatment of patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease, under rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor I blocker (ARB).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2012
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2012
CompletedFirst Posted
Study publicly available on registry
November 30, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedSeptember 24, 2015
September 1, 2015
2.5 years
July 25, 2012
September 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in urine protein creatinine ratio
9 months
Secondary Outcomes (3)
Change from baseline in urine albumin creatinine ratio
9 months
Change from baseline in 24 hour albuminuria
9 months
Change from baseline in estimated GFR
9 months
Other Outcomes (4)
Change from baseline in urine protein creatinine ratio
3-12 months
Change in urine albumin creatinine ratio
3-12 months
Change from baseline in 24 hour albuminuria
3-12 months
- +1 more other outcomes
Study Arms (3)
NEFECON 8 mg/day
EXPERIMENTALNEFECON 8 mg/day (2 active + 2 placebo capsules daily) for 9 months
NEFECON 16 mg/day
EXPERIMENTALNEFECON 16 mg/day (4 active capsules daily) for 9 months
Placebo
PLACEBO COMPARATORPlacebo (4 placebo capsules daily) for 9 months
Interventions
All patients will receive a maximum recommended daily dose of an ACEI and/or ARB (or maximum tolerated dose not exceeding the maximum recommended daily dose) for the duration of the treatment and follow-up phases.
All patients will receive a maximum recommended daily dose of an ACEI and/or ARB (or maximum tolerated dose not exceeding the maximum recommended daily dose) for the duration of the treatment and follow-up phases.
Eligibility Criteria
You may qualify if:
- Female or male patients ≥18 years
- Biopsy-verified IgA nephropathy
- Urine protein creatinine ratio ≥0.5 g/g OR urine protein ≥0.75 g/24hr
- Estimated GFR (using the CKD-EPI formula) OR measured GFR ≥50 mL/min per 1.73 m2 OR ≥45 mL/min per 1.73m2 for patients on a maximum recommended or maximum tolerated dose of an ACEI and/or ARB
- Willing to change antihypertensive medication regimen if applicable
- Willing and able to give informed consent
You may not qualify if:
- Secondary forms of IgA nephropathy as defined by the treating physician (for example, Henoch-Schönlein purpura patients and those with associated alcoholic cirrhosis)
- Presence of crescent formation in ≥50% of glomeruli assessed on renal biopsy
- Kidney transplanted patients 4. Severe gastrointestinal disorders (including peptic ulcer disease and inflammatory bowel disease) which may impair drug effect, or other conditions which could modify the effect of the trial drug as judged by the Investigator
- Patients currently treated with systemic immunosuppressive or systemic corticosteroid drugs (excluding topical or nasal steroids) or have been previously treated for more than one week within the last 24 months.
- Patients currently treated chronically (daily dosing) with inhaled corticosteroid drugs or have previously been treated chronically for more than one month within the last 12 months
- Patients previously treated with immunosuppressive or systemic corticosteroids for the treatment of IgA nephropathy
- Patients unable to take oral medication or intolerant to budesonide or other corticosteroid preparations
- Patients with known allergy or intolerance to ACEI, ARB or to any component of the trial drug formulation
- Patients with acute or chronic infectious disease incl. hepatitis, HIV positive patients and patients with chronic urinary tract infections
- Severe liver disease according to the discretion of the Investigator
- Patients with Type 1 or 2 diabetes
- Patients with uncontrolled cardiovascular disease as judged by the Investigator
- Patients with current malignancy or history of malignancy during the last three years
- For women only; pregnant or breast feeding or unwilling to use adequate contraception during the trial (only women of child bearing potential)
- Completion of the Run-in Phase
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
University Hospital of Antwerp
Antwerp, Belgium
Imelda Hospital
Bonheiden, Belgium
Ghent University Hospital
Ghent, Belgium
University Hospitals Leuven
Leuven, Belgium
Heilig Hartziekenhuis Roeselare-Menen
Roeselare, Belgium
University Hospital
Olomouc, Czechia
Charles University & General University Hospital
Prague, Czechia
Institut klinické a experimentální medicíny
Prague, Czechia
Rigshospitalet
Copenhagen, Denmark
Herlev Hospital
Herlev, Denmark
Odense University Hospital
Odense, Denmark
Helsinki University Central Hospital
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
Turku University Central Hospital
Turku, Finland
RWTH Aachen
Aachen, Germany
Klinikum Augsburg
Augsburg, Germany
Charité Hospital
Berlin, Germany
Charité-Virchow Clinic
Berlin, Germany
Vivantes Klinikum im Friedrichshain
Berlin, Germany
Klinikum-Bremen-Mitte
Bremen, Germany
University Hospital Carl Gustav Carus
Dresden, Germany
Studienzentrum Karlstrasse
Düsseldorf, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Universitätsmedizin Göttingen
Göttingen, Germany
University Hospital
Heidelberg, Germany
University of Jena
Jena, Germany
Universitätsklinikum Magdeburg
Magdeburg, Germany
Universität München
Munich, Germany
Universitätsklinikum Münster
Münster, Germany
Universitätsklinikum Regensburg
Regensburg, Germany
Deutsche Klinik für Diagnostik
Wiesbaden, Germany
Würzburg University Hospital
Würzburg, Germany
Policlinico di Bari
Bari, Italy
Azienda Ospedaliera G. Brotzu
Cagliari, Italy
Ospedale A Manzoni
Lecco, Italy
Bassini Hospital
Milan, Italy
Ospedale S. G. Bosco
Torino, Italy
Belcolle Hospital
Viterbo, Italy
University Medical Center
Leiden, Netherlands
Fundación Puigver
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
12 de Octubre Hospital
Madrid, Spain
Fundación Jimenez Diaz Hospital
Madrid, Spain
Hospital Universitario Gregorio Marañon
Madrid, Spain
Central sjukhuset
Karlstad, Sweden
Karlstad Central Hospital
Karlstad, Sweden
University Hospital
Linköping, Sweden
Danderyds Hospital
Stockholm, Sweden
Karolinska University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
Belfast City Hospital
Belfast, United Kingdom
Ulster Hospital
Belfast, United Kingdom
Royal Derby Hospital
Derby, United Kingdom
Edinburgh Royal Infirmary
Edinburgh, United Kingdom
Western Infirmary
Glasgow, United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Leicester General Hospital
Leicester, United Kingdom
James Cook University Hospital
Middlesbrough, United Kingdom
Related Publications (2)
Fellstrom BC, Barratt J, Cook H, Coppo R, Feehally J, de Fijter JW, Floege J, Hetzel G, Jardine AG, Locatelli F, Maes BD, Mercer A, Ortiz F, Praga M, Sorensen SS, Tesar V, Del Vecchio L; NEFIGAN Trial Investigators. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial. Lancet. 2017 May 27;389(10084):2117-2127. doi: 10.1016/S0140-6736(17)30550-0. Epub 2017 Mar 28.
PMID: 28363480DERIVEDYeo SC, Liew A, Barratt J. Emerging therapies in immunoglobulin A nephropathy. Nephrology (Carlton). 2015 Nov;20(11):788-800. doi: 10.1111/nep.12527.
PMID: 26032537DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bengt Fellström, MD, PhD
Professor of Medicine Department of Medical Sciences, Renal Medicine Uppsala University Hospital, Sweden
- STUDY DIRECTOR
Alex Mercer, PhD
Pharmalink AB, Stockholm, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2012
First Posted
November 30, 2012
Study Start
December 1, 2012
Primary Completion
June 1, 2015
Study Completion
September 1, 2015
Last Updated
September 24, 2015
Record last verified: 2015-09