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

Browse trials for

• Nephritis 245
• Lupus Nephritis 331

Keywords

• nephritis
• atacicept

Nephritis

245 studies on the registry are indexed under Nephritis; 56 are open to participants now.

This study's enrollment of 6 is below the median of 49 across 156 interventional studies indexed under Nephritis.

Lead sponsor

EMD Serono is the lead sponsor of 88 studies on the registry; none are open to participants now.

Study arms

• Experimental
  Atacicept Plus Mycophenolate mofetil Plus Corticosteroids

  Drug: Atacicept · Drug: Mycophenolate mofetil · Drug: Corticosteroids

• Placebo comparator
  Placebo Plus Mycophenolate mofetil Plus Corticosteroids

  Drug: Mycophenolate mofetil · Drug: Placebo · Drug: Corticosteroids

Interventions

• DrugAtacicept

  Atacicept will be administered at a dose of 150 milligram (mg) subcutaneously (SC) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks.

• DrugMycophenolate mofetil

  MMF will be administered orally with a starting dose of 500 mg twice daily for 1 week, will be increased to 1000 mg twice daily for 1 week, then it will be adjusted to 1500 mg or lower twice daily as per investigator's discretion.

• DrugPlacebo

  Placebo will be administered at a dose of 150 mg SC twice weekly for 4 weeks followed by 150 mg SC once weekly for 48 weeks.

• DrugCorticosteroids

  High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever is less will be administered for 4 Weeks and will be tapered to 7.5 to 10 mg/day up to Week 12.

Primary outcomes

1. Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response

   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

Secondary outcomes

1. Percentage of Participants With Normalization of Renal Function

   Time frame: At Week 52

2. Number of Participants With New Lupus Flares

   Time frame: At Week 52

Baseline characteristics

Publications

• Ginzler EM, Wax S, Rajeswaran A, Copt S, Hillson J, Ramos E, Singer NG. Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial. Arthritis Res Ther. 2012 Feb 7;14(1):R33. doi: 10.1186/ar3738. PubMed 22325903 ↗