Primary Immunoglobulin a Nephropathy (IgAN)Phase 3NCT05534919
Efficacy and Safety in Chinese Patients with Immunoglobulin a Nephropathy (IgAN) Who Have Completed Study Nef-301
A Phase 3 study testing Nefecon in people with Primary Immunoglobulin a Nephropathy (IgAN), run by Everest Medicines (Singapore) Pte. Ltd. at 1 site in China.
Trial summary
This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in Chinese patients who have completed Nef-301 and continue to be treated with a stable dose of Renin-angiotensin system (RAS) inhibitor therapy (Angiotensin-converting enzyme inhibitors (ACEIs)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Immunoglobulin a Nephropathy (IgAN)
- What is being tested?
- Nefecon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2022to 17 Jul 2024
- Phase
- Phase 3
- 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
Who may be able to join
- Patients that completed study Nef-301.
- On a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or maximum tolerated dose according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.
- Willing and able to provide written informed consent.
- Urine protein to creatinine ratio (UPCR) equal to or more than 0.5 g/gram or Average proteinuria equal or more than 0.75 g/day.
- eGFR equal to or more than 30 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Who cannot join
- Systemic diseases that may cause mesangial Immunoglobulin A (IgA) deposition.
- Patients who have undergone a kidney transplant.
- Patients with presence of other glomerulopathies and/or nephrotic syndrome.
- Patients with acute, chronic, or latent infectious disease including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), and chronic urinary tract infections.
- Patients with liver cirrhosis, as assessed by the Investigator.
- Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled.
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- Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator.
- Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator.
- Patients with diagnosed malignancy within the past 5 years.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: An Open-label Extention (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients with IgA Nephropathy Who Have Completed Study Nef-301 in China
This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in Chinese patients who have completed Nef-301 and continue to be treated with a stable dose of Renin-angiotensin system (RAS) inhibitor therapy (Angiotensin-converting enzyme inhibitors (ACEIs) and/or Angiotensin II type I receptor blockers (ARBs).
Read the detailed description
This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in Chinese patients with Immunoglobulin A nephropathy (IgAN) who have completed Nef 301 study and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs).
During Study open-label extension (OLE) study, patients will receive Nefecon for a 9-month period. The patient will come for a follow-up visit at 12 months after first dose.
- Being tested
- Nefecon
- 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
Nefecon is taken orally as capsules once daily for 9 months.
| Study group | Role | What they receive |
|---|---|---|
| Nefecon active treatment | Experimental | Nefecon 16mg once daily for 9 months. Receives: Drug: Nefecon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine protein to creatinine ratio (UPCR) after 9 months
The outcome is measured as urine protein to creatinine ratio (UPCR) based on 24 hour urine collections at 9 months following the first dose of Nefecon compared to baseline.following the first dose of Nefecon compared to baseline.
Measured: 9 months
Change in estimated glomerular filtration rate(eGFR) at 9 months
The outcome is measured as change in eGFR at 9 months following the first dose of Nefecon compared to baseline.
Measured: 9 months
The incidence of treatment emergent adverse events
Adverse event data collection
Measured: from enrollment up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start9 Dec 2022
- Primary completion17 Jul 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunoglobulin a Nephropathy (IgAN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open label, single-arm study with active treatment.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Everest Medicines (Singapore) Pte. Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jicheng Lv, Doctor, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534919
- Sponsor's protocol ID
- ES103002
- Status last verified
- Jan 2024
- First submitted
- 6 Sep 2022
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extention (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients with IgA Nephropathy Who Have Completed Study Nef-301 in China
- ClinicalTrials.gov ID
- NCT05534919
- Acronym / sponsor ID
- ES103002
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Everest Medicines (Singapore) Pte. Ltd.University, hospital or other
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in Chinese patients who have completed Nef-301 and continue to be treated with a stable dose of Renin-angiotensin system (RAS) inhibitor therapy (Angiotensin-converting enzyme inhibitors (ACEIs) and/or Angiotensin II type I receptor blockers (ARBs).
Detailed description
This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in Chinese patients with Immunoglobulin A nephropathy (IgAN) who have completed Nef 301 study and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs).
During Study open-label extension (OLE) study, patients will receive Nefecon for a 9-month period. The patient will come for a follow-up visit at 12 months after first dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open label, single-arm study with active treatment.
| Arm | Type | Receives |
|---|---|---|
| Nefecon active treatment | Experimental | Drug: NefeconNefecon 16mg once daily for 9 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients that completed study Nef-301.
- On a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or maximum tolerated dose according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.
- Willing and able to provide written informed consent.
- Urine protein to creatinine ratio (UPCR) equal to or more than 0.5 g/gram or Average proteinuria equal or more than 0.75 g/day.
- eGFR equal to or more than 30 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Key exclusion criteria (9 listed)
- Systemic diseases that may cause mesangial Immunoglobulin A (IgA) deposition.
- Patients who have undergone a kidney transplant.
- Patients with presence of other glomerulopathies and/or nephrotic syndrome.
- Patients with acute, chronic, or latent infectious disease including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), and chronic urinary tract infections.
- Patients with liver cirrhosis, as assessed by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NefeconNefecon is taken orally as capsules once daily for 9 months. | Drug | Nefecon active treatment |
Primary outcome
Change in urine protein to creatinine ratio (UPCR) after 9 months
Time frame: 9 months
The outcome is measured as urine protein to creatinine ratio (UPCR) based on 24 hour urine collections at 9 months following the first dose of Nefecon compared to baseline.following the first dose of Nefecon compared to baseline.
Change in estimated glomerular filtration rate(eGFR) at 9 months
Time frame: 9 months
The outcome is measured as change in eGFR at 9 months following the first dose of Nefecon compared to baseline.
The incidence of treatment emergent adverse events
Time frame: from enrollment up to 12 months
Adverse event data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jicheng Lv, Doctor principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nefecon in people with Primary Immunoglobulin a Nephropathy (IgAN), run by Everest Medicines (Singapore) Pte. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 in urine protein to creatinine ratio (UPCR) after 9 months (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.