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Primary IgA NephropathyPhase 2NEFIGANNCT01738035

The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease

A Phase 2 study testing NEFECON in people with Primary IgA Nephropathy, run by Calliditas Therapeutics AB at 58 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary IgA Nephropathy
What is being tested?
NEFECON
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
58 sitesin 10 countries
Study dates
Dec 2012to Sep 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Screening Inclusion Criteria:

  1. Female or male patients ≥18 years
  2. Biopsy-verified IgA nephropathy
  3. Urine protein creatinine ratio ≥0.5 g/g OR urine protein ≥0.75 g/24hr
  4. 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
  5. Willing to change antihypertensive medication regimen if applicable
  6. Willing and able to give informed consent

Screening Exclusion Criteria:

  1. Secondary forms of IgA nephropathy as defined by the treating physician (for example, Henoch-Schönlein purpura patients and those with associated alcoholic cirrhosis)
  2. Presence of crescent formation in ≥50% of glomeruli assessed on renal biopsy
  3. 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
  4. 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.
  5. 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
  6. Patients previously treated with immunosuppressive or systemic corticosteroids for the treatment of IgA nephropathy
  7. Patients unable to take oral medication or intolerant to budesonide or other corticosteroid preparations
  8. Patients with known allergy or intolerance to ACEI, ARB or to any component of the trial drug formulation
  9. Patients with acute or chronic infectious disease incl. hepatitis, HIV positive patients and patients with chronic urinary tract infections
  10. Severe liver disease according to the discretion of the Investigator
  11. Patients with Type 1 or 2 diabetes
  12. Patients with uncontrolled cardiovascular disease as judged by the Investigator
  13. Patients with current malignancy or history of malignancy during the last three years
  14. For women only; pregnant or breast feeding or unwilling to use adequate contraception during the trial (only women of child bearing potential)

Randomization Inclusion Criteria:

  1. Completion of the Run-in Phase
  2. Urine protein creatinine ratio ≥0.5 g/g OR urine protein ≥0.75 g/24hr
  3. eGFR ≥45 mL/min per 1.73 m2 using CKD-EPI formula OR measured GFR ≥45 mL/min per 1.73 m2

Randomization Exclusion Criteria:

  1. Unacceptable blood pressure defined as a systolic value >160 mm Hg or diastolic >100 mm Hg
  2. eGFR (CKD-EPI) loss >30% over the entire duration of the Run-in Phase
  3. For women only; pregnant or breast feeding or unwilling to use adequate contraception during the trial (only women of child bearing potential)

Trial locations and contacts

58 sites in 10 countries.

58 sites in 10 countries

Germany18 sites

  • RWTH Aachen

    Aachen

  • Klinikum Augsburg

    Augsburg

  • Charité Hospital

    Berlin

  • Charité-Virchow Clinic

    Berlin

  • Vivantes Klinikum im Friedrichshain

    Berlin

  • Klinikum-Bremen-Mitte

    Bremen

  • University Hospital Carl Gustav Carus

    Dresden

  • Studienzentrum Karlstrasse

    Düsseldorf

  • Universitätsklinikum Erlangen

    Erlangen

  • Universitätsmedizin Göttingen

    Göttingen

  • University Hospital

    Heidelberg

  • University of Jena

    Jena

  • Universitätsklinikum Magdeburg

    Magdeburg

  • Universität München

    Munich

  • Universitätsklinikum Münster

    Münster

  • Universitätsklinikum Regensburg

    Regensburg

  • Deutsche Klinik für Diagnostik

    Wiesbaden

  • Würzburg University Hospital

    Würzburg

Other trials in Germany

United Kingdom8 sites

  • Belfast City Hospital

    Belfast

  • Ulster Hospital

    Belfast

  • Royal Derby Hospital

    Derby

  • Edinburgh Royal Infirmary

    Edinburgh

  • Western Infirmary

    Glasgow

  • The Leeds Teaching Hospitals NHS Trust

    Leeds

  • Leicester General Hospital

    Leicester

  • James Cook University Hospital

    Middlesbrough

Other trials in United Kingdom

Italy6 sites

  • Policlinico di Bari

    Bari

  • Azienda Ospedaliera G. Brotzu

    Cagliari

  • Ospedale A Manzoni

    Lecco

  • Bassini Hospital

    Milan

  • Ospedale S. G. Bosco

    Torino

  • Belcolle Hospital

    Viterbo

Other trials in Italy

Sweden6 sites

  • Central sjukhuset

    Karlstad

  • Karlstad Central Hospital

    Karlstad

  • University Hospital

    Linköping

  • Danderyds Hospital

    Stockholm

  • Karolinska University Hospital

    Stockholm

  • Uppsala University Hospital

    Uppsala

Other trials in Sweden

Belgium5 sites

  • University Hospital of Antwerp

    Antwerp

  • Imelda Hospital

    Bonheiden

  • Ghent University Hospital

    Ghent

  • University Hospitals Leuven

    Leuven

  • Heilig Hartziekenhuis Roeselare-Menen

    Roeselare

Other trials in Belgium

Spain5 sites

  • Fundación Puigver

    Barcelona

  • Hospital Universitario Vall d'Hebron

    Barcelona

  • 12 de Octubre Hospital

    Madrid

  • Fundación Jimenez Diaz Hospital

    Madrid

  • Hospital Universitario Gregorio Marañon

    Madrid

Other trials in Spain

Czechia3 sites

  • University Hospital

    Olomouc

  • Charles University & General University Hospital

    Prague

  • Institut klinické a experimentální medicíny

    Prague

Other trials in Czechia

Denmark3 sites

  • Rigshospitalet

    Copenhagen

  • Herlev Hospital

    Herlev

  • Odense University Hospital

    Odense

Other trials in Denmark

Finland3 sites

  • Helsinki University Central Hospital

    Helsinki

  • Tampere University Hospital

    Tampere

  • Turku University Central Hospital

    Turku

Other trials in Finland

Netherlands1 site

  • University Medical Center

    Leiden

Other trials in Netherlands

About this study

Official title: 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

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).

Read the detailed description

NEFECON is an add-on treatment to other medications for nephropathy symptoms and kidney function, including ACEI and/or ARBs. Rigorous blood pressure control will be achieved over a 6-month Run-in Phase in which ACEI and/or ARB will be dosed to target a blood pressure of <130/80 mm Hg and UPCR <0.5 g/g. Patients who complete the Run-in Phase, and despite optimized ACEI and/or ARB therapy, have a UPCR ≥0.5 g/g OR urine protein ≥0.75 g/24hr will be eligible for randomization and entry into the treatment phase of the trial. Patients will remain on their ACEI and/or ARB dosing regimen for the duration of the trial.

Patients entering the treatment phase will be administered NEFECON (8 mg/day OR 16 mg/day) OR placebo for a phase of 9 months. A 3-month follow-up phase will follow on from the treatment phase, of which the first 2 weeks will be used to taper the dose of those patients that received 16 mg/day dosing to 8 mg/day, with the placebo and 8 mg/day groups receiving placebo to retain blinding.

Being tested
NEFECON, Placebo
Keywords
IgA nephropathy
Medical subject headings
Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NEFECONDrug

    Also called Budesonide modified-released capsules (4 mg/capsule)

    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.

  • PlaceboOther

    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.

Study groups in NCT01738035
Study groupRoleWhat they receive
NEFECON 8 mg/dayExperimentalNEFECON 8 mg/day (2 active + 2 placebo capsules daily) for 9 months
Receives: Drug: NEFECON
NEFECON 16 mg/dayExperimentalNEFECON 16 mg/day (4 active capsules daily) for 9 months
Receives: Drug: NEFECON
PlaceboPlacebo comparatorPlacebo (4 placebo capsules daily) for 9 months
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in urine protein creatinine ratio

    Measured: 9 months

Secondary outcomes (3)

  1. Change from baseline in urine albumin creatinine ratio

    Measured: 9 months

  2. Change from baseline in 24 hour albuminuria

    Measured: 9 months

  3. Change from baseline in estimated GFR

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionJun 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01738035
Sponsor's protocol ID
Nef-202
Other IDs
2012-001923-11
Acronym
NEFIGAN
Status last verified
Sep 2015
First submitted
25 Jul 2012
Last updated
24 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Howie AJ, Lalayiannis AD. The Oxford Classification Should Remain the Gold Standard for Classification of IgA Nephropathy: CON. Kidney360. 2026 Oct 1;7(10):2382-2384. doi: 10.34067/KID.0000001083. Epub 2026 Feb 9. No abstract available.

    PubMed 41661687

  • Wimbury D, Muto M, Bhachu JS, Scionti K, Brown J, Molyneux K, Seikrit C, Maixnerova D, Perez-Alos L, Garred P, Floege J, Tesar V, Fellstrom B, Coppo R, Barratt J. Targeted-release budesonide modifies key pathogenic biomarkers in immunoglobulin A nephropathy: insights from the NEFIGAN trial. Kidney Int. 2024 Feb;105(2):381-388. doi: 10.1016/j.kint.2023.11.003. Epub 2023 Nov 25. No abstract available.

    PubMed 38008160

  • 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.

    PubMed 28363480

  • Yeo SC, Liew A, Barratt J. Emerging therapies in immunoglobulin A nephropathy. Nephrology (Carlton). 2015 Nov;20(11):788-800. doi: 10.1111/nep.12527.

    PubMed 26032537

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NEFECON in people with Primary IgA Nephropathy, run by Calliditas Therapeutics AB at 58 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in Germany, United Kingdom, Italy, Sweden, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in urine protein creatinine ratio (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01738035, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015.

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