NCT02062684

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administration in addition to standard therapy in patients with biopsy proven IgA Nephropathy with persistent proteinuria of between 1-6 g/day.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2013

Typical duration for phase_2

Geographic Reach
10 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

3.8 years

First QC Date

February 12, 2014

Last Update Submit

September 14, 2017

Conditions

IgA Nephropathy

Keywords

IgANIgA NephropathyA-623BlisibimodKidney DiseasePersistent proteinuria

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects achieving reduction in proteinuria from baseline

    24 weeks

Secondary Outcomes (6)

  • Change from baseline in serum immunoglobulins IgA, IgG and IgM

    24 weeks

  • Percent reduction from baseline in plasma cells and B-cell subsets

    24 weeks

  • Percent change from baseline in complement C3 and C4

    24 weeks

  • Proportion of subjects progressing to End Stage Renal Disease

    Approximately 104 weeks

  • Proportion of subjects achieving reduction in proteinuria from baseline

    Approximately 104 weeks

  • +1 more secondary outcomes

Study Arms (2)

Blisibimod

EXPERIMENTAL

Blisibimod administered subcutaneously

Drug: Blisibimod

Placebo

PLACEBO COMPARATOR

Placebo administered subcutaneously

Drug: Placebo

Interventions

BlisibimodDRUG
Blisibimod
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age, inclusive
  • Biopsy-proven IgA nephropathy
  • Receiving stable, clinically-optimized ACEI and/or ARB
  • Proteinuria ≥ 1g/24hr but ≤ 6g/24hr at 2 consecutive time points

You may not qualify if:

  • Clinical or histologic evidence of non-IgA-related glomerulonephritis
  • IgA nephropathy with greater than 50% glomerulosclerosis or cortical scarring
  • Meets eGFR criteria
  • History of treatment with oral or parenteral corticosteroids within 3 months or immunosuppressants within 6 months
  • Malignancy within past 5 years
  • Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
  • Liver disease
  • Neutropenia
  • Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections
  • History of active tuberculosis or a history of tuberculosis infection
  • Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Investigator Site 852

Olomouc, Czechia

Location

Investigator 851

Prague, Czechia

Location

Investigator Site 905

Düsseldorf, 40210, Germany

Location

Investigator Site 101

Hong Kong, Hong Kong

Location

Investigator Site 603

Kajang, 43000, Malaysia

Location

Investigator Site 402

Quezon City, 1101, Philippines

Location

Investigator Site 401

Quezon City, Philippines

Location

Investigator Site 202

Singapore, 169608, Singapore

Location

Investigator Site 201

Singapore, 308433, Singapore

Location

Investigator Site 305

Busan, 612-896, South Korea

Location

Investigator Site 306

Busan, 614-735, South Korea

Location

Investigator Site 303

Daejeon, 301-721, South Korea

Location

Investigator Site 301

Seoul, 110-744, South Korea

Location

Investigator Site 302

Seoul, 137-701, South Korea

Location

Investigator Site 704

Changhua, 500, Taiwan

Location

Investigator Site 705

Tainan, 70428, Taiwan

Location

Investigator Site 504

Bangkok, 10330, Thailand

Location

Investigator Site 505

Bangkok, 10400, Thailand

Location

Investigator Site 503

Bangkok, 10700, Thailand

Location

Investigator Site 501

Chang Mai, 50200, Thailand

Location

Investigator Site 806

Bradford, United Kingdom

Location

Investigator Site 801

Leicester, United Kingdom

Location

Investigator Site 803

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 26032537DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGAKidney Diseases

Interventions

AMG623 peptibody

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 14, 2014

Study Start

June 1, 2013

Primary Completion

March 1, 2017

Study Completion

June 30, 2017

Last Updated

September 18, 2017

Record last verified: 2017-09

Locations

DE(1)TW(2)CZ(2)TH(4)KR(5)HK(1)GB(3)PH(2)SG(2)MY(1)