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Etanercept for the Treatment of Lupus Nephritis

This study has been terminated.
(The perceived risk-benefit ratio for individuals with early active RA)
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00447265
First received: March 12, 2007
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
Results First Received: October 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Lupus Nephritis
Interventions: Drug: Etanercept
Drug: Lupus Treatment- Standard of Care
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participant recruitment occurred at 6 sites. All sites were affiliated with a university and utilized a lupus clinic and outside referrals for recruitment. The first site (UCSF) was activated on 1 Feb 2008. The remaining 5 sites (Feinstein, Rochester, Colorado, Duke, and UAB) were activated over the next year.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The participant signed an informed consent before study screening procedures commenced to assess eligibility criteria (lupus diagnosis with active nephritis, positive ANA, presence of dsDNA antibodies, and stable medication regimens of either mycophenolate mofetil (MMF, CellCept®, Myfortic®) or azathioprine at the screening visit.

Reporting Groups
  Description
Etanercept Participants (or their caretaker) would administer 50 mg etanercept subcutaneous injections once weekly for 24 weeks. They would continue receiving their usual treatment with corticosteroids and either mycophenolate mofetil or azathioprine.
Placebo Participants (or their caretaker) would administer 50 mg placebo subcutaneous injections once weekly for 24 weeks. They would continue receiving their usual treatment with corticosteroids and either mycophenolate mofetil or azathioprine.

Participant Flow:   Overall Study
    Etanercept     Placebo  
STARTED     1     0  
COMPLETED     0 [1]   0  
NOT COMPLETED     1     0  
Physician Decision                 1                 0  
[1] The participant completed treatment and discontinued follow-up at week 39 after randomization



  Baseline Characteristics
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Reporting Groups
  Description
Etanercept Participant self-administered 50 mg etanercept subcutaneous injections once weekly for 24 weeks. She continued receiving her usual treatment with corticosteroids and mycophenolate mofetil.

Baseline Measures
    Etanercept  
Number of Participants  
[units: participants]
 		  1  
Age  
[units: Participants]
 		 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Gender  
[units: Participants]
 		 
Female     1  
Male     0  
Region of Enrollment  
[units: Participants]
 		 
United States     1  
Day 0 GFR (mL/min per 1.73m^2) [1]
[units: mL/min/1.73m^2]
Mean ( Full Range ) 		  96.9  
  ( 96.9 to 96.9 )  
Day 0 random urine protein  
[units: mg/dL]
Mean ( Full Range ) 		  141  
  ( 141 to 141 )  
SLEDAI total score [2]
[units: Score]
Mean ( Full Range ) 		  22  
  ( 22 to 22 )  
[1] Glomerular filtration rate (GFR) is calculated based on the "Modification of Diet in Renal Disease" equation (Levy, AS, Coresh J, Galk E et al, National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med, 139(2): 137-47, 2003)
[2] The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a concise measure of lupus disease activity with excellent test-retest reliability and high responsiveness to clinically important changes in the disease. The total score is derived from ratings on 24 conditions plus the Physician's Global Assessment; 0 indicates inactive disease and the maximum theoretical score is 105 with higher scores representing increased disease activity.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Adverse Events (AEs)Grade 3 or Higher Experienced by Participant During Treatment Phase of Study   [ Time Frame: 24 Weeks ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participant Adverse Events (AEs) From Baseline to Early Study Withdrawal Visit   [ Time Frame: 39 Weeks ]
  Show Outcome Measure 2

3.  Secondary:   Percent of Participants Who Achieved a Renal Response at Week 24   [ Time Frame: Week 24 ]
  Show Outcome Measure 3

4.  Secondary:   Time to Participant's Renal Response   [ Time Frame: First 24 Weeks of Study Period ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Time to Participant's Renal Response
Measure Description

Time to when participant achieved a renal response[1]

[1]A renal response is defined as: 1) 50% reduction in proteinuria compared to baseline as measured by urinary protein: creatinine ratio; and 2) stable or improving renal function as defined by the Glomerular filtration rate (GFR) calculated based on the "Modification of Diet in Renal Disease" equation (Levy, AS, Coresh J, Galk E et al, National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med, 139(2): 137-47, 2003)
Time Frame First 24 Weeks of Study Period  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Etanercept Etanercept plus standard of care

Measured Values
    Etanercept  
Number of Participants Analyzed  
[units: participants]
 		  1  
Time to Participant's Renal Response  
[units: Weeks]
 		  24  

No statistical analysis provided for Time to Participant's Renal Response



5.  Secondary:   Participant Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) Score at Baseline and at Early Study Withdrawal Visit   [ Time Frame: Baseline, Week 39 (Early Study Withdrawal Visit) ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants With a C to B Score Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Mucocutaneous Score   [ Time Frame: Baseline, Week 24 ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants With a B to D Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Musculoskeletal Score   [ Time Frame: Baseline, Week 24 ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants With an A to B Score Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Renal Score   [ Time Frame: Baseline, Week 24 ]
  Show Outcome Measure 8

9.  Secondary:   Participant Medical Outcome Study Short-Form 36 (SF-36) Physical Component Score at Baseline and Week 24   [ Time Frame: Baseline, Week 24 ]
  Show Outcome Measure 9

10.  Secondary:   Participant Medical Outcome Study Short Form 36 (SF-36) Mental Component Score at Baseline and Week 24   [ Time Frame: Baseline, Week 24 ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study terminated early with 1 subject enrolled. Based on safety info from other trials, the protocol chairs decided possible risks to patients outweighed the potential benefits. Analysis of groups is not possible. Study objectives cannot be met.  


Results Point of Contact:  
Name/Title: Associate Director for Clinical Research
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsGov@niaid.nih.gov


Publications:


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00447265     History of Changes
Other Study ID Numbers: DAIT ALN01
Study First Received: March 12, 2007
Results First Received: October 7, 2011
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration