Atacicept in Lupus Nephritis Patients Taking Stable Regimen of Mycophenolate Mofetil
This study has been terminated.
(Please see Purpose Statement below)
Sponsor:
EMD Serono
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01369628
First received: June 7, 2011
Last updated: December 21, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lupus Nephritis |
Drug: Atacicept |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase Ib, Multicenter, Open Label, Dose-Escalating, Repeat-Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Atacicept When Administered to Subjects With Lupus Nephritis on a Stable Regimen of Mycophenolate Mofetil (MMF) With or Without Corticosteroids |
Resource links provided by NLM:
Drug Information available for:
Mycophenolic acid
Mycophenolate sodium
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
U.S. FDA Resources
Further study details as provided by EMD Serono:
Primary Outcome Measures:
- The nature (preferred terms) and incidence of AEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Frequency tables summarizing the observed number of AEs by System Organ Class (SOC) and preferred term will be presented per regimen.
- Proportion of subjects fulfilling criteria for an Atacicept dose modification due to an IgG decrease [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Percentages of subjects fulfilling the criteria (prespecified in the protocol) for an atacicept dose modification due to a decrease in IgG will be presented.
- The frequency and severity of laboratory abnormalities [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]The incidence of subjects given each atacicept regimen who have shifts from Baseline in serum creatinine, serum albumin, urinary protein, or Hematology test (counts of white blood cells, neutrophils, lymphocytes, platelets) of at least 2 grades will be presented. Grading will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 toxicity grading, using the worst grade post-baseline during the 12-week treatment period.
Secondary Outcome Measures:
- The nature (preferred terms) and incidence of AEs [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]Frequency tables summarizing the observed number of AEs by System Organ Class (SOC) and preferred term will be presented per regimen.
- Proportion of subjects fulfilling criteria for an Atacicept dose modification due to an IgG decrease [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]Percentages of subjects fulfilling the criteria (prespecified in the protocol) for an atacicept dose modification due to a decrease in IgG will be presented.
- The frequency and severity of laboratory abnormalities [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]The incidence of subjects given each atacicept regimen who have shifts from Baseline in serum creatinine, serum albumin, urinary protein, or Hematology test (counts of white blood cells, neutrophils, lymphocytes, platelets) of at least 2 grades will be presented. Grading will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 toxicity grading, using the worst grade post-baseline during the 12-week treatment period.
| Enrollment: | 1 |
| Study Start Date: | June 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
1 arm with the 3 following dose regimens:
|
Drug: Atacicept
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT01369628 History of Changes |
| Other Study ID Numbers: | EMR 700461_014 |
| Study First Received: | June 7, 2011 |
| Last Updated: | December 21, 2011 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Spain: AEMPS |
Keywords provided by EMD Serono:
|
Open label Dose Escalating Phase Ib |
Additional relevant MeSH terms:
|
Lupus Nephritis Nephritis Glomerulonephritis Kidney Diseases Urologic Diseases Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Mycophenolate mofetil |
Mycophenolic Acid Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013