Trial · NCT00430677
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
NCT00430677, Phase 2, Phase 3, Terminated, Bristol-Myers Squibb; results first posted 2012-05-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis. Trials, record NCT00430677. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00430677
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
- NCT number
- NCT00430677
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 423 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Corticosteroids (prednisone or prednisolone), Abatacept, Abatacept, Mycophenolate mofetil (MMF), Abatacept
- First posted
- 2007-02-02
- Last updated
- 2015-03-20
- Results first posted
- 2012-05-11
Source ClinicalTrials.gov
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period | Day 1 (randomization) to 12 months. | Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate \[GFR\] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio \<30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported. |
| Secondary | Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period | Day 1 to 12 months | Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate \[GFR\] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio \<30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported. |
| Secondary | Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period | At Month 12 from Day 1 | Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate \[GFR\] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio \<30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported. |
| Secondary | Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology) | Day 1 (randomization) to 12 months. | RI is defined as meeting all of the following criteria. Renal function: If MDRD is abnormal at screening, within 10% of the MDRD at screening; if MDRD is 60-89 at screening, greater than or equal to 50% improvement based on the screening value or 90% or greater of MDRD at screening; if MDRD is 15-59 at screening, if MDRD is normal at screening-within 10% of the MDRD at screening. Proteinuria: improvement greater than or equal to 50% from screening. Hematuria: red blood cell (RBC)count within normal limit of central laboratory. Pyuria: white blood cell (WBC) count within normal limit of central laboratory. Cylindruria: No RBC or WBC casts. |
| Secondary | Participants Achieving Renal Improvement (RI) or CRR at Month 12 During Short-term Period | At Month 12 from Day 1 | CRR defined as meeting all of 5 criteria. RF: (Glomerular filtration rate \[GFR\] calculated using MDRD equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio \<30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported. |
| Secondary | Number of Months CRR Was Maintained During Short-term Period | Day 1 (randomization) to 12 Months | Durability of CRR, defined as the number of months (number of consecutive planned visits beyond Day 15) a participant met the definition of CRR during the double-blind treatment period. Refer to outcome 1 for description of CRR. |
| Secondary | Baseline Renal Function Over Time During Short-term Period | Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365 | Baseline (BL) renal function, as estimated by calculation of the MDRD (Modification of Diet in Renal Disease) equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m\^2) = 175 \* (Scr)\^-1.154 \* (Age)\^-0.203 \* (0.742 if female) \* (1.212 if African American) (conventional units). mL, milliliters; min, minute; m\^2, meters squared; Scr, serum creatinine. A negative value indicates worsening. |
| Secondary | Change in Renal Function From Baseline Over Time During Short-term Period | Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365 | Mean change from baseline in renal function, as estimated by calculation of the MDRD equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m\^2) = 175 \* (Scr)\^-1.154 \* (Age)\^-0.203 \* (0.742 if female) \* (1.212 if African American) (conventional units). mL, milliliters; min, minute; m\^2, meters squared; Scr, serum creatinine. A positive value indicates improvement. Change from baseline=Post-baseline-baseline value. |
| Secondary | Baseline and Post Baseline Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index During Short-term Period | Baseline (Day 1), Post baseline (Month 12 or 28 days after last dose) | SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity. |
| Secondary | Number of Participants Achieving Renal Response (RR) at Month 12 During Short-term Period | Month 12 | RR is defined as meeting BOTH of the following criteria:RENAL FUNCTION: Less than or equal to 25% increase from baseline;PROTEINURIA: Greater than or equal to 50% improvement in the urine protein/creatinine ratio with one of the following - urine protein/creatinine ratio (UPCR) \<113 mg/mmol,, if the baseline ratio was \<=339 mg/mmol OR UPCR \<339 mg/mmol,if the baseline ratio \> 339 mg/mmol. A participant was considered as achieving RR if response criteria at both months 11 and 12 (Days 337 and 365, respectively) were met. For 95% CI within each group, normal approximation is used if n\>=5. |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 registered outcomesOutcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period | Day 1 (randomization) to 12 months. | All randomized participants who received treatment. Includes participants who died and who were censored at the time of discontinuation. | days | NUMBER |
| SECONDARY | Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period | Day 1 to 12 months | All randomized participants who received treatment. Participants who discontinued early without meeting the confirmed CRR criteria were imputed as nonresponders. | Participants | NUMBER |
| SECONDARY | Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period | At Month 12 from Day 1 | All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication. | Participants | NUMBER |
| SECONDARY | Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology) | Day 1 (randomization) to 12 months. | All randomized participants who received treatment. Includes participants who died and who were censored at the time of discontinuation | Days | MEDIAN |
| SECONDARY | Participants Achieving Renal Improvement (RI) or CRR at Month 12 During Short-term Period | At Month 12 from Day 1 | All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication. | Participants | NUMBER |
| SECONDARY | Number of Months CRR Was Maintained During Short-term Period | Day 1 (randomization) to 12 Months | All randomized participants who received participants. | Months | MEDIAN |
| SECONDARY | Baseline Renal Function Over Time During Short-term Period | Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365 | n= Number of participants with measurements for that time point. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment. | milliliters per minute (mL/min)/1.73 m^2 | MEAN |
| SECONDARY | Change in Renal Function From Baseline Over Time During Short-term Period | Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365 | ITT population (all randomized and treated subjects). n= Number of participants with both baseline and post-baseline measurements for that time point. | milliliters per minute (mL/min)/1.73 m^2 | MEAN |
| SECONDARY | Baseline and Post Baseline Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index During Short-term Period | Baseline (Day 1), Post baseline (Month 12 or 28 days after last dose) | n=Participants with both post-baseline and baseline measurements showing non-reversible changes in the SLICC/ACR Damage Index (i.e., Change from Baseline greater than or equal to 0). | Units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants Achieving Patient Response (PR) at Month 12 During the Short-term Period | Month 12 | All randomized participants who received treatment. | Participants | NUMBER |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 outcomesResults by group895
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period | Abatacept 30/10 mg/kg | NA | NE to NE | days | |
| Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period | Abatacept 10/10 mg/kg | NA | NE to NE | days | |
| Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period | Placebo | NA | NE to NE | days | |
| Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period | Abatacept 30/10 mg/kg | 22 | Participants | ||
| Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period | Abatacept 10/10 mg/kg | 27 | Participants | ||
| Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period | Placebo | 20 | Participants | ||
| Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period | Abatacept 30/10 mg/kg | 9 | Participants | ||
| Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period | Abatacept 10/10 mg/kg | 11 | Participants | ||
| Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period | Placebo | 8 | Participants | ||
| Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology) | Abatacept 30/10 mg/kg | 141 | 95% Confidence Interval 88 to 169 | Days |
1 to 10 of 895Source ClinicalTrials.gov
See all 895 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Short-term Period | STARTED | Abatacept 30/10 mg/kg | 99 | |
| Short-term Period | STARTED | Abatacept 10/10 mg/kg | 99 | |
| Short-term Period | STARTED | Placebo | 100 | |
| Short-term Period | COMPLETED | Abatacept 30/10 mg/kg | 76 | |
| Short-term Period | COMPLETED | Abatacept 10/10 mg/kg | 74 | |
| Short-term Period | COMPLETED | Placebo | 78 | |
| Short-term Period | NOT COMPLETED | Abatacept 30/10 mg/kg | 23 | |
| Short-term Period | NOT COMPLETED | Abatacept 10/10 mg/kg | 25 | |
| Short-term Period | NOT COMPLETED | Placebo | 22 | |
| Long-term Extension Period | STARTED | Abatacept 30/10 mg/kg | 70 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events417
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Abatacept 30/10 mg/kg | 30 | 99 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Abatacept 10/10 mg/kg | 29 | 99 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Placebo | 32 | 99 | |
| other | GASTROENTERITIS | Infections and infestations | Abatacept 30/10 mg/kg | 9 | 99 | |
| other | GASTROENTERITIS | Infections and infestations | Abatacept 10/10 mg/kg | 7 | 99 | |
| other | GASTROENTERITIS | Infections and infestations | Placebo | 3 | 99 | |
| other | URINARY TRACT INFECTION | Infections and infestations | Abatacept 30/10 mg/kg | 9 | 99 | |
| other | URINARY TRACT INFECTION | Infections and infestations | Abatacept 10/10 mg/kg | 10 | 99 | |
| other | URINARY TRACT INFECTION | Infections and infestations | Placebo | 17 | 99 | |
| other | BRONCHITIS | Infections and infestations | Abatacept 30/10 mg/kg | 7 | 99 |
1 to 10 of 417Source ClinicalTrials.gov
See all 417 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abatacept 30/10 mg/kg | ||
| Total, all-cause mortality | Abatacept 10/10 mg/kg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Abatacept 30/10 mg/kg | 83 | 99 |
| Total, other adverse events | Abatacept 10/10 mg/kg | 75 | 99 |
| Total, other adverse events | Placebo | 84 | 99 |
| Total, serious adverse events | Abatacept 30/10 mg/kg | 33 | 99 |
| Total, serious adverse events | Abatacept 10/10 mg/kg | 28 | 99 |
| Total, serious adverse events | Placebo | 31 | 100 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00430677
GET https://conductscience.org/api/trials/v1/NCT00430677/registered?page=2