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Trial record 22 of 148 for:    lupus AND Lupus Nephritis

Etanercept for the Treatment of Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT00447265
Recruitment Status : Terminated (The perceived risk-benefit ratio for individuals with early active RA)
First Posted : March 14, 2007
Results First Posted : December 19, 2011
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Lupus Nephritis
Interventions Drug: Etanercept
Drug: Lupus Treatment- Standard of Care
Drug: Placebo
Enrollment 1

Recruitment Details 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 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.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 1 0
Completed 0 [1] 0
Not Completed 1 0
Reason Not Completed
Physician Decision             1             0
[1]
The participant completed treatment and discontinued follow-up at week 39 after randomization
Arm/Group Title Etanercept
Hide Arm/Group Description Participant self-administered 50 mg etanercept subcutaneous injections once weekly for 24 weeks. She continued receiving her usual treatment with corticosteroids and mycophenolate mofetil.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
Day 0 GFR (mL/min per 1.73m^2)   [1] 
Mean (Full Range)
Unit of measure:  mL/min/1.73m^2
Number Analyzed 1 participants
96.9
(96.9 to 96.9)
[1]
Measure Description: 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)
Day 0 random urine protein  
Mean (Full Range)
Unit of measure:  mg/dL
Number Analyzed 1 participants
141
(141 to 141)
SLEDAI total score   [1] 
Mean (Full Range)
Unit of measure:  Score
Number Analyzed 1 participants
22
(22 to 22)
[1]
Measure Description: 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.
1.Primary Outcome
Title Number of Adverse Events (AEs)Grade 3 or Higher Experienced by Participant During Treatment Phase of Study
Hide Description

Number of adverse events (AEs) or serious adverse events (SAEs) Grade 3 or higher experienced by participant over the duration of the treatment period. [1]

[1] This study graded the severity of AEs experienced by the study participant according to the criteria set forth in the National Cancer Institute’s Common Terminology Criteria for Adverse Events Version 3.0.

Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:
Etanercept plus standard of care
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Events
0
2.Secondary Outcome
Title Number of Participant Adverse Events (AEs) From Baseline to Early Study Withdrawal Visit
Hide Description Number of participant AEs during the trial. This study graded the severity of AEs experienced by the study participant according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0.
Time Frame 39 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:
Etanercept plus standard of care
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Events
3
3.Secondary Outcome
Title Percent of Participants Who Achieved a Renal Response at Week 24
Hide Description

Percent of study participants who achieved a renal response at 24 weeks.[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 Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:
Etanercept plus standard of care
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Percent of Participants
100
4.Secondary Outcome
Title Time to Participant's Renal Response
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:
Etanercept plus standard of care
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Weeks
24
5.Secondary Outcome
Title 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 DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:
Etanercept plus standard of care
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Points on a scale
Baseline SLEDAI Score 22
Week 39 SLEDAI score 8
6.Secondary Outcome
Title 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
Hide Description Reported here is the number of participants with a change in their BILAG Mucocutaneous Score from C (at baseline) to B (at week 24). A single alphabetic score (A through E) is used to denote disease severity. The BILAG score is a converted numerical score (A=9, B=3, C=1, D=0, E=0). A maximum mucocutaneous score of 9 signifies higher disease activity and a score of 0 is indicative of inactive systematic lupus erythematosus (SLE) in the specified organ system.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:
Etanercept plus standard of care
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Participants
1
7.Secondary Outcome
Title Number of Participants With a B to D Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Musculoskeletal Score
Hide Description Reported here is the number of participants with a change in their BILAG Musculoskeletal Score from B (at baseline) to D (at week 24). A single alphabetic score (A through E) is used to denote disease severity. The BILAG score is a converted numerical score (A=9, B=3, C=1, D=0, E=0).A maximum musculoskeletal score of 9 signifies higher disease activity and a score of 0 is indicative of inactive systematic lupus erythematosus (SLE) in the specified organ system.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:
Etanercept plus standard of care
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Participants
1
8.Secondary Outcome
Title 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
Hide Description Reported here is the number of participants with a change in their BILAG Renal Score from A (at baseline) to B (at week 24). A single alphabetic score (A through E) is used to denote disease severity. The BILAG score is a converted numerical score (A=9, B=3, C=1, D=0, E=0).A maximum renal score of 9 signifies higher disease activity and a score of 0 is indicative of inactive systematic lupus erythematosus (SLE) in the specified organ system
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:
Etanercept plus standard of care
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Participants
1
9.Secondary Outcome
Title Participant Medical Outcome Study Short-Form 36 (SF-36) Physical Component Score at Baseline and Week 24
Hide Description

Reported here is the participant baseline and week 24 SF-36 Physical Component scores. The SF-36 measures 8 domains: physical functioning, role limitations due to physical health, body pain, social functioning, mental health, role limitations due to emotional problems, vitality, and general health perceptions[1]. The Physical Component scores of the SF-36 range from 0 to 100; 0 equals worst health state. Higher numbers reported here indicate more improvement in condition from baseline.

[1]Ref: Ware JE, Sherbourne CD. The MOS36-item short-form health survey Med Care. 1992; 30:473-483.

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:
Etanercept plus standard of care
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Score on a scale
Baseline SF-36 Physical Component Score 44.4
Week 24 SF-36 Physical Component Score 42.3
10.Secondary Outcome
Title Participant Medical Outcome Study Short Form 36 (SF-36) Mental Component Score at Baseline and Week 24
Hide Description

Reported here are the participant SF-36 Mental Component scores at baseline and week 24. The SF-36 measures 8 domains: physical functioning, role limitations due to physical health, bodily pain, social functioning, mental health, role limitations due to emotional problems, vitality, and general health perceptions.[1] The Mental Component score of the SF-36 ranges from 0 to 100; 0 equals worst health state. Higher numbers reported here indicate more improvement in condition from baseline.

[1]Ref: Ware JE, Sherbourne CD. The MOS36-item short-form health survey. Med Care. 1992; 30:473-483

Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:
Etanercept plus standard of care
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Score on a scale
Baseline SF-36 Mental Component Score 31.4
Week 24 SF-36 Mental Component Score 52.3
Time Frame Baseline to 39 weeks
Adverse Event Reporting Description This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0
 
Arm/Group Title Etanercept
Hide Arm/Group Description Participant received self-administered 50 mg etanercept subcutaneous injections once weekly for 24 weeks while continuing to receive her usual lupus treatment of corticosteroids and mycophenolate mofetil.
All-Cause Mortality
Etanercept
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Etanercept
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Infections and infestations   
Otitis media   1/1 (100.00%)  1
Injury, poisoning and procedural complications   
Muscle Strain   1/1 (100.00%)  1
Skin and subcutaneous tissue disorders   
Rash   1/1 (100.00%)  1
Indicates events were collected by systematic assessment
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.
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.
Results Point of Contact
Name/Title: Associate Director for Clinical Research
Organization: DAIT/NIAID
Phone: 301-594-7669
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00447265     History of Changes
Other Study ID Numbers: DAIT ALN01
First Submitted: March 12, 2007
First Posted: March 14, 2007
Results First Submitted: October 7, 2011
Results First Posted: December 19, 2011
Last Update Posted: February 12, 2013