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Atacicept in Lupus Nephritis Patients Taking Stable Regimen of Mycophenolate Mofetil

NCT ID: NCT01369628

Last Updated: 2013-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

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The sponsor electively terminated the study because the risk mitigation measures, deemed necessary after an unforeseen safety event, could not be effectively implemented within this protocol while maintaining study timelines within a reasonable time frame.

Detailed Description

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This study will evaluate atacicept's effects in subjects who have lupus nephritis, at least 2 g/day of protein in the urine, and are already taking mycophenolate mofetil. The evaluations will include the concentrations of atacicept in the blood, the effects of atacicept on immunoglobulins (antibodies), and any side effects. The first subjects will be given a low dose. Following periodic reviews of the trial data, subsequent subjects are planned to receive one of 2 progressively higher doses of atacicept.

Conditions

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Lupus Nephritis

Keywords

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Open label Dose Escalating Phase Ib

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

1 arm with the 3 following dose regimens:

1. Regimen 1: Atacicept 25 mg weekly for 12 weeks
2. Regimen 2: Atacicept 75 mg weekly for 12 weeks
3. Regimen 3: Atacicept 150 mg weekly for 12 weeks

Group Type EXPERIMENTAL

Atacicept

Intervention Type DRUG

1. Regimen 1: Atacicept 25 mg weekly for 12 weeks
2. Regimen 2: Atacicept 75 mg weekly for 12 weeks
3. Regimen 3: Atacicept 150 mg weekly for 12 weeks

Interventions

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Atacicept

1. Regimen 1: Atacicept 25 mg weekly for 12 weeks
2. Regimen 2: Atacicept 75 mg weekly for 12 weeks
3. Regimen 3: Atacicept 150 mg weekly for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects, ≥ 18 years of age, who provide written informed consent
* Subjects must have a diagnosis of SLE satisfying ≥ 4 of 11 ACR criteria, and must have had a renal biopsy during screening or within the previous 18 months demonstrating class III (A or A/C), IV (A or A/C), V, or concomitant III/V or IV/V LN as defined by the International Society of Nephrology/Renal Pathology Society (ISN/RPS).
* Subjects must have a urine protein: creatinine ratio ≥ 2 mg/mg (≥ 226.2 mg/mmol), and either a positive test for antinuclear antibody (ANA) (HEp-2 ANA ≥ 1:80) and/or anti-double stranded deoxyribonucleic acid (dsDNA) (≥ 30 IU/mL) at screening.
* Subjects must have started induction therapy for LN at least 5 months prior to Trial Day 1, be considered to have received continuous treatment for LN during the 5 months prior to Trial Day 1, and have received a stable dose of MMF ≥ 1 g/day, with or without corticosteroids, for at least 8 weeks prior to Trial Day 1.

Exclusion Criteria

* Recent changes in immunosuppressant, ACD inhibitors for ARBs
* Use of azathioprine, cyclosporine, tacrolimus, or cyclophosphamide or other biologics within 8 weeks prior to Trial Day 1.
* Serum IgG \< 6 g/L
* Estimated Glomerular Filtration Rate (GFR) ≤ 30 mL/min per 1.73 m2
* History of Demyelinating Disease
* Significant Hematuria and/or Proteinuria due to a reason(s) other than LN. Evaluation should be done according to the local standard of care
* Breast feed or pregnancy
* Legal Incapacity or limited legal capacity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EMD Serono

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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EMD Serono Inc., One Technology Place

Rockland, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/20302641

Related Info

http://www.ncbi.nlm.nih.gov/pubmed/19743503

Related Info

http://www.ncbi.nlm.nih.gov/pubmed/19395457

Related Info

http://www.ncbi.nlm.nih.gov/pubmed/18050206

Related Info

http://www.ncbi.nlm.nih.gov/pubmed/10801128

Related Info

Other Identifiers

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EMR 700461_014

Identifier Type: -

Identifier Source: org_study_id