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Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)

Primary Purpose

IgA Nephropathy, Berger Disease

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Atacicept

Placebo to match Atacicept

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring Berger Disease, Berger's Disease, IGA Glomerulonephritis, IGA Nephropathy, Iga Nephropathy 1, Immunoglobulin A Nephropathy Nephritis, IGA Type Nephropathy, IGA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Must have the ability to understand and sign a written informed consent form
Male or female of ≥18 years of age
Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
Total urine protein excretion >0.75g per 24-hour or urine protein to creatinine ratio (UPCR) >0.75 mg/mg based on a 24-hour urine sample during the Screening Period
eGFR ≥ 30 mL/min/1.73 m2, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose
Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg

Key Exclusion Criteria:

IgAN secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (i.e., Henoch-Schonlein purpura), systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis
Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% of eGFR within 3 months of screening)
Evidence of nephrotic syndrome within 6 months of screening (serum albumin <30g/L in association with UPCR >3.5 mg/mg
Total urine protein excretion ≥ 5g per 24-hour or urine protein to creatinine ratio (UPCR) ≥ 5 mg/mg based on a 24-hour urine sample during the Screening Period
Renal or other organ transplantation prior to, or expected during the study
Concomitant chronic renal disease in addition to IgAN
Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening
History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test

Sites / Locations

ORIGIN 3 Global Site Contact InformationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atacicept Dose 150mg

Placebo to match Atacicept (Part C/D)

Arm Description

Atacicept 150mg once weekly subcutaneous (SC) injections

Placebo to match Atacicept once weekly subcutaneous (SC) injection

Outcomes

Primary Outcome Measures

Change from baseline in urine protein to creatinine ratio (UPCR)

UPCR based on 24 hour urine collection

Secondary Outcome Measures

Annualized rate of change in estimated glomerular filtration rate (eGFR)

eGFR calculated by CKD-EPI formula

Full Information

NCT ID

NCT04716231

First Posted

January 11, 2021

Last Updated

July 17, 2023

Sponsor

Vera Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04716231

Brief Title

Atacicept in Subjects With IgA Nephropathy

Acronym

ORIGIN 3

Official Title

A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With IgA Nephropathy (IgAN)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 23, 2023 (Actual)

Primary Completion Date

June 2025 (Anticipated)

Study Completion Date

July 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vera Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)

Detailed Description

This is a multi-part study comprising of the original Phase 2b study (active, no longer recruiting) and the addition of a separate pivotal Phase 3 study (active, recruiting). After the completion of the primary results for the Ph 2b dose ranging study, the pivotal study (active, recruiting) will evaluate the efficacy and safety of atacicept compared to placebo in reducing proteinuria in subjects with IgAN and persistent proteinuria despite being on a maximally tolerated dose (MTD) of a RASi. Safety, eGFR, serum immunoglobulins and Gd-IgA1 will also be clinically assessed. The clinical study is comprised of a 104wk double-blind treatment period, followed by a 52wk open-label treatment period and a 26wk safety follow-up period. The UPCR primary endpoint will be assessed after the first 200 patients are randomized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IgA Nephropathy, Berger Disease

Keywords

Berger Disease, Berger's Disease, IGA Glomerulonephritis, IGA Nephropathy, Iga Nephropathy 1, Immunoglobulin A Nephropathy Nephritis, IGA Type Nephropathy, IGA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

376 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Atacicept Dose 150mg

Arm Type

Experimental

Arm Description

Atacicept 150mg once weekly subcutaneous (SC) injections

Arm Title

Placebo to match Atacicept (Part C/D)

Arm Type

Placebo Comparator

Arm Description

Placebo to match Atacicept once weekly subcutaneous (SC) injection

Intervention Type

Biological

Intervention Name(s)

Atacicept

Other Intervention Name(s)

VT-001

Intervention Description

Once weekly subcutaneous (SC) injections by prefilled syringe

Intervention Type

Other

Intervention Name(s)

Placebo to match Atacicept

Intervention Description

Once weekly subcutaneous (SC) injections by prefilled syringe

Primary Outcome Measure Information:

Title

Change from baseline in urine protein to creatinine ratio (UPCR)

Description

UPCR based on 24 hour urine collection

Time Frame

36 Weeks

Secondary Outcome Measure Information:

Title

Annualized rate of change in estimated glomerular filtration rate (eGFR)

Description

eGFR calculated by CKD-EPI formula

Time Frame

52 and 104 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Must have the ability to understand and sign a written informed consent form Male or female of ≥18 years of age Total urine protein excretion ≥1.0 g per 24-hour or urine protein to creatinine ratio (UPCR) ≥1.0 mg/mg based on a 24-hour urine sample during the Screening Period Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years eGFR ≥ 30 mL/min/1.73 m2, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose at Screening Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg Key Exclusion Criteria: IgAN secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (i.e., Henoch-Schonlein purpura), systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis Total urine protein excretion ≥ 5g per 24-hour or urine protein to creatinine ratio (UPCR) ≥ 5 mg/mg based on a 24-hour urine sample during the Screening Period Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% of eGFR within 3 months of screening) Evidence of nephrotic syndrome within 6 months of screening (serum albumin <30g/L in association with UPCR >3.5 mg/mg Renal or other organ transplantation prior to, or expected during the study Concomitant chronic renal disease in addition to IgAN Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vera Therapeutics, Inc. Clinical Trials Information

Phone

650-770-0077

clinicaltrials@veratx.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rubeen Israni

Organizational Affiliation

Sr. Director, Clinical Development

Official's Role

Study Director

Facility Information:

Facility Name

ORIGIN 3 Global Site Contact Information

City

Brisbane

State/Province

California

ZIP/Postal Code

94005

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brisbane, California

Phone

650-770-0077

clinicaltrials@veratx.com

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.veratx.com

Description

Vera Therapeutics, Inc Company Website

URL

https://www.theoriginiganstudy.com/origin3-study

Description

ORIGIN 3 Study Website

Learn more about this trial

Atacicept in Subjects With IgA Nephropathy

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