Efficacy and Safety in Chinese Patients with Immunoglobul... | NCT05534919

Studies
Efficacy and Safety in Chinese Patients with Immunoglobulin a Nephropathy (IgAN) Who Have Completed Study Nef-301

NCT05534919

Sponsor

Everest Medicines (Singapore) Pte. Ltd.

Status

Completed

Last Update Posted

Nov 12, 2024Actual

Enrollment

21Actual

Phase

Phase 3

Conditions

Primary Immunoglobulin a Nephropathy (IgAN)

Interventions

Nefecon

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2022Actual

Primary Completion Date

Jul 17, 2024Actual

Completion Date

Jul 17, 2024Actual

First Submitted Date

Sep 6, 2022

First Submission Date that Met QC Criteria

Sep 6, 2022

First Posted Date

Sep 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2024

Last Update Posted Date

Nov 12, 2024Actual

Description Module

Brief 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) 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nefecon active treatment	Experimental	Nefecon 16mg once daily for 9 months.	Drug: Nefecon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nefecon	Drug	Nefecon is taken orally as capsules once daily for 9 months.	Nefecon active treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	9 months
The incidence of treatment emergent adverse events	Adverse event data collection	from enrollment up to 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases