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Trial record 46 of 148 for:    lupus AND Lupus Nephritis

The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT00573157
Recruitment Status : Terminated (The study was terminated due to unanticipated safety issues)
First Posted : December 14, 2007
Results First Posted : March 23, 2016
Last Update Posted : March 23, 2016
Sponsor:
Collaborator:
ZymoGenetics
Information provided by (Responsible Party):
EMD Serono

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lupus Nephritis
Interventions Drug: Atacicept
Drug: Mycophenolate mofetil
Drug: Placebo
Drug: Corticosteroids
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids Placebo Plus Mycophenolate Mofetil Plus Corticosteroids
Hide Arm/Group Description Atacicept was administered subcutaneously (SC) at a loading dose of 150 milligram (mg) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose corticosteroids (CS) of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12. Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
Period Title: Overall Study
Started 4 2
Completed 0 0
Not Completed 4 2
Reason Not Completed
Adverse Event             3             1
Other             1             1
Arm/Group Title Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids Placebo Plus Mycophenolate Mofetil Plus Corticosteroids Total
Hide Arm/Group Description Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12. Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12. Total of all reporting groups
Overall Number of Baseline Participants 4 2 6
Hide Baseline Analysis Population Description
Baseline analysis population included all the participants randomized in the trial.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 2 participants 6 participants
36.8  (11.3) 36.0  (25.5) 36.5  (14.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
Female
3
  75.0%
1
  50.0%
4
  66.7%
Male
1
  25.0%
1
  50.0%
2
  33.3%
1.Primary Outcome
Title Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response
Hide Description Complete renal response (CRR): from baseline, a return to within 10% of normal for renal function (assessed by calculated glomerular filtration rate [GFR]), improvement in proteinuria (urine protein/creatinine ratio <0.5) & resolution of hematuria. Partial response (PR): from baseline, a <= 10% worsening in renal function ( by calculated GFR); 50% improvement in proteinuria (assessed by urine protein/creatinine ratio) & resolution of hematuria, Non-response (NR): Neither criteria for CR or PR was met. Subjects were also deemed NR if they had treatment failure, regardless of CR or PR status. Subjects cannot be treatment failures. A response of CRR was confirmed if the Week 52 value is CRRand if the Week 48 value is CRR and at least 4 weeks apart from Week 52 /if the Week 48 value was missing/ less than 4 weeks from Week 52, then the Week 56 response must be CRR - if the Week 52 value was missing, then Week 48 and Week 56 must be CRR.
Time Frame At Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.
Arm/Group Title Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids Placebo Plus Mycophenolate Mofetil Plus Corticosteroids
Hide Arm/Group Description:
Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Percentage of Participants With Normalization of Renal Function
Hide Description [Not Specified]
Time Frame At Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.
Arm/Group Title Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids Placebo Plus Mycophenolate Mofetil Plus Corticosteroids
Hide Arm/Group Description:
Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants With New Lupus Flares
Hide Description [Not Specified]
Time Frame At Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.
Arm/Group Title Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids Placebo Plus Mycophenolate Mofetil Plus Corticosteroids
Hide Arm/Group Description:
Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From the first dose of trial medication to 24-Week follow-up after last dose of trial medication.
Adverse Event Reporting Description A Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
 
Arm/Group Title Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids Placebo Plus Mycophenolate Mofetil Plus Corticosteroids
Hide Arm/Group Description Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12. Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
All-Cause Mortality
Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids Placebo Plus Mycophenolate Mofetil Plus Corticosteroids
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids Placebo Plus Mycophenolate Mofetil Plus Corticosteroids
Affected / at Risk (%) Affected / at Risk (%)
Total   3/4 (75.00%)   0/2 (0.00%) 
Blood and lymphatic system disorders     
Anaemia * 2  1/4 (25.00%)  0/2 (0.00%) 
Infections and infestations     
Empyema * 2  1/4 (25.00%)  0/2 (0.00%) 
Pneumonia * 2  1/4 (25.00%)  0/2 (0.00%) 
Pneumonia legionella * 2  1/4 (25.00%)  0/2 (0.00%) 
Sepsis * 2  1/4 (25.00%)  0/2 (0.00%) 
Nervous system disorders     
Syncope * 2  1/4 (25.00%)  0/2 (0.00%) 
Renal and urinary disorders     
Renal failure acute * 2  1/4 (25.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumothorax * 1  1/4 (25.00%)  0/2 (0.00%) 
Pulmonary embolism * 2  1/4 (25.00%)  0/2 (0.00%) 
Vascular disorders     
Hypertensive crisis * 2  1/4 (25.00%)  0/2 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 11.1
2
Term from vocabulary, MedDRA Version 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids Placebo Plus Mycophenolate Mofetil Plus Corticosteroids
Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   1/2 (50.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/4 (25.00%)  0/2 (0.00%) 
Haemolytic anaemia * 1  1/4 (25.00%)  0/2 (0.00%) 
Thrombotic microangiopathy * 1  1/4 (25.00%)  0/2 (0.00%) 
Cardiac disorders     
Tachycardia * 1  1/4 (25.00%)  1/2 (50.00%) 
Atrial fibrillation * 1  1/4 (25.00%)  0/2 (0.00%) 
Palpitations * 1  0/4 (0.00%)  1/2 (50.00%) 
Eye disorders     
Dry eye * 1  1/4 (25.00%)  0/2 (0.00%) 
Gastrointestinal disorders     
Nausea * 1  1/4 (25.00%)  1/2 (50.00%) 
Abdominal pain * 1  0/4 (0.00%)  1/2 (50.00%) 
Diarrhoea * 1  1/4 (25.00%)  0/2 (0.00%) 
Rectal haemorrhage * 1  1/4 (25.00%)  0/2 (0.00%) 
Vomiting * 1  1/4 (25.00%)  0/2 (0.00%) 
General disorders     
Injection site erythema * 1  1/4 (25.00%)  0/2 (0.00%) 
Injection site haematoma * 1  0/4 (0.00%)  1/2 (50.00%) 
Injection site pain * 1  1/4 (25.00%)  0/2 (0.00%) 
Oedema * 1  1/4 (25.00%)  0/2 (0.00%) 
Oedema peripheral * 1  1/4 (25.00%)  0/2 (0.00%) 
Pyrexia * 1  1/4 (25.00%)  0/2 (0.00%) 
Immune system disorders     
Hypogammaglobulinaemia * 1  2/4 (50.00%)  0/2 (0.00%) 
Infections and infestations     
Influenza * 1  1/4 (25.00%)  0/2 (0.00%) 
Injury, poisoning and procedural complications     
Contusion * 1  1/4 (25.00%)  0/2 (0.00%) 
Renal haematoma * 1  1/4 (25.00%)  0/2 (0.00%) 
Wrist fracture * 1  1/4 (25.00%)  0/2 (0.00%) 
Investigations     
Blood immunoglobulin G decreased * 1  1/4 (25.00%)  0/2 (0.00%) 
Metabolism and nutrition disorders     
Hypokalaemia * 1  2/4 (50.00%)  0/2 (0.00%) 
Anorexia * 1  1/4 (25.00%)  0/2 (0.00%) 
Hypoalbuminaemia * 1  1/4 (25.00%)  0/2 (0.00%) 
Hypophosphataemia * 1  1/4 (25.00%)  0/2 (0.00%) 
Type 2 diabetes mellitus * 1  1/4 (25.00%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/4 (0.00%)  1/2 (50.00%) 
Pain in extremity * 1  1/4 (25.00%)  0/2 (0.00%) 
Nervous system disorders     
Dysgeusia * 1  0/4 (0.00%)  1/2 (50.00%) 
Tremor * 1  1/4 (25.00%)  0/2 (0.00%) 
Psychiatric disorders     
Insomnia * 1  1/4 (25.00%)  0/2 (0.00%) 
Mood altered * 1  1/4 (25.00%)  0/2 (0.00%) 
Renal and urinary disorders     
Dysuria * 1  1/4 (25.00%)  0/2 (0.00%) 
Renal failure acute * 1  1/4 (25.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  1/4 (25.00%)  0/2 (0.00%) 
Epistaxis * 1  1/4 (25.00%)  0/2 (0.00%) 
Oropharyngeal pain * 1  1/4 (25.00%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne * 1  1/4 (25.00%)  0/2 (0.00%) 
Leukocytoclastic vasculitis * 1  0/4 (0.00%)  1/2 (50.00%) 
Rash * 1  0/4 (0.00%)  1/2 (50.00%) 
Vascular disorders     
Hypertension * 1  1/4 (25.00%)  0/2 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.0
The study was terminated due to unanticipated safety issues.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Prior to publishing results, Institution and Principal Investigator (PI) must first provide Sponsor with a copy of proposed publication for review at least 30 days prior to submission. If Institution and PI do not agree to modification, they shall so notify Sponsor and postpone submission for additional 60 days to allow Sponsor to seek legal remedies or file patent applications. There is a need for coordinated approach to any publication of results from sites for any multi-site study.
Results Point of Contact
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00573157     History of Changes
Other Study ID Numbers: 28113
493G01
First Submitted: December 11, 2007
First Posted: December 14, 2007
Results First Submitted: February 22, 2016
Results First Posted: March 23, 2016
Last Update Posted: March 23, 2016