Trial · NCT00774852

Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis

NCT00774852, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2014-10-09

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis. Trials, record NCT00774852. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00774852

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis
NCT number: NCT00774852
Status: Completed
Phases: Phase 2
Enrollment: 137 participants, actual
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions: Lupus Nephritis, Lupus Erythematosus, Systemic
Interventions: abatacept, cyclophosphamide, azathioprine, prednisone, abatacept placebo, azathioprine placebo
First posted: 2008-10-17
Last updated: 2016-02-08
Results first posted: 2014-10-09

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Complete Response	Week 24	Complete response definition: a serum creatinine \<= 1.2 mg/dL or \<=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio \<0.5, and prednisone dose tapered to \<=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as CR failures for all subsequent visits. CRs are those who successfully responded to treatment and have minimal activity of their lupus nephritis.
Secondary	Number of Participants With Partial Response	Week 24	Outcome measure description: Partial response definition: a serum creatinine \<= 1.2 mg/dL or \<= to 125% of the higher value at either screening or baseline visit, and improvement (reduction) \>= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol. Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as complete response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis.
Secondary	Number of Participants With a Complete or Partial Response	Week 52	Complete response: a serum creatinine \<= 1.2 mg/dL or \<=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio \<0.5, and prednisone dose tapered to \<=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder. Partial response: a serum creatinine \<= 1.2 mg/dL or \<= to 125% of the higher value at either screening or baseline visit, and improvement \>= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol. Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs successfully responded to treatment and have minimal activity of their lupus nephritis. Partial responders showed some response to treatment and low activity of their lupus nephritis.
Secondary	Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52	Week 52	Complete response definition: a serum creatinine \<= 1.2 mg/dL or \<=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio \<0.5, and prednisone dose tapered to \<=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs are those who successfully responded to treatment and had minimal activity of their lupus nephritis.
Secondary	Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response	Week 24	A complete proteinuria and prednisone response is defined as urine protein-to-creatinine ratio \<0.5 and prednisone dose tapered to \<= 10mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Complete responders are those who successfully responded to treatment and have minimal activity of their lupus nephritis.
Secondary	Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response	Week 24	A partial proteinuria and prednisone response is defined as an improvement (reduction) of \>=50% in the urine protein-to-creatinine ratio at either visit -1 or 0, and prednisone dose has been tapered to 10 mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis.
Secondary	Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study	Week 104	A participant who did not meet the criteria for either a complete response or a partial response at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the site investigator judged that the participant could benefit from continued participation. Non responders did not respond to treatment and lupus activity is moderate to severe.
Secondary	Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study , Achieving a Complete or Partial Response	Week 52	A participant who did not meet the criteria for either a complete response (CR) or a partial response (PR) at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the investigator judged that the participant may benefit from continued participation. CR definition: a serum creatinine \<= 1.2 mg/dL or \<=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio \<0.5, and prednisone dose tapered to \<=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a CR. PR definition: a serum creatinine \<= 1.2 mg/dL or \<= to 125% of the higher value at either screening or baseline, and improvement (reduction) \>= to 50% in the urine protein to creatinine ratio at either screening or baseline, and prednisone dose has been tapered to 10 mg/day.
Secondary	Lupus Disease Activity - Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104	Week 104	Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores. Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. One measure used to assess disease activity is the number of participants who were anti-dsDNA positive at baseline but negative at Week 104. Going from positive to negative is indicative of lowered lupus activity.
Secondary	Lupus Disease Activity - Negative Anti-dsDNA	Week 104	Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores. Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. This measure was the number of participants who had negative anti-dsDNA at Week 104. Having a negative score is indicative of low lupus disease activity.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Complete Response	Week 24	Intent-to-treat	participants	NUMBER
SECONDARY	Number of Participants With Partial Response	Week 24	Intent-to-treat	participants	NUMBER
SECONDARY	Number of Participants With a Complete or Partial Response	Week 52	Intent-to-treat	participants	NUMBER
SECONDARY	Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52	Week 52	Intent-to-treat	participants	NUMBER
SECONDARY	Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response	Week 24	Intent-to-treat	participants	NUMBER
SECONDARY	Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response	Week 24	Intent-to-treat	participants	NUMBER
SECONDARY	Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study	Week 104	Intent-to-treat	participants	NUMBER
SECONDARY	Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study , Achieving a Complete or Partial Response	Week 52	Intent-to-treat
SECONDARY	Lupus Disease Activity - Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104	Week 104	Participants from Intent-to-treat population who had positive anti-dsDNA at baseline and completed Week 104.	participants	NUMBER
SECONDARY	Lupus Disease Activity - Negative Anti-dsDNA	Week 104	Intent-to-treat participants who completed Week 104.	participants	NUMBER

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group56

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Complete Response	Abatacept	22	participants
Number of Participants With Complete Response	Placebo	21	participants
Number of Participants With Partial Response	Abatacept	39	participants
Number of Participants With Partial Response	Placebo	40	participants
Number of Participants With a Complete or Partial Response	Week 24 Complete Response: Abatacept	12	participants
Number of Participants With a Complete or Partial Response	Week 24 Complete Response: Placebo	14	participants
Number of Participants With a Complete or Partial Response	Week 24 Partial Response: Abatacept	13	participants
Number of Participants With a Complete or Partial Response	Week 24 Partial Response: Placebo	13	participants
Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52	Week 24 Complete Response: Abatacept	11	participants
Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52	Week 24 Complete Response: Placebo	13	participants

1 to 10 of 56Source ClinicalTrials.gov

See all 56 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Abatacept	69
Overall Study	STARTED	Placebo	68
Overall Study	COMPLETED	Abatacept	24
Overall Study	COMPLETED	Placebo	27
Overall Study	NOT COMPLETED	Abatacept	45
Overall Study	NOT COMPLETED	Placebo	41

Source ClinicalTrials.gov

Adverse events148

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	Leukopenia	Blood and lymphatic system disorders	Abatacept	10	69	13
other	Leukopenia	Blood and lymphatic system disorders	Placebo	8	68	9
other	Nausea	Gastrointestinal disorders	Abatacept	7	69	8
other	Nausea	Gastrointestinal disorders	Placebo	6	68	13
other	Vomiting	Gastrointestinal disorders	Abatacept	6	69	6
other	Vomiting	Gastrointestinal disorders	Placebo	3	68	3
other	Adverse drug reaction	General disorders	Abatacept	3	69	3
other	Adverse drug reaction	General disorders	Placebo	5	68	6
other	Oedema peripheral	General disorders	Abatacept	6	69	6
other	Oedema peripheral	General disorders	Placebo	3	68	3

1 to 10 of 148Source ClinicalTrials.gov

See all 148 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Abatacept
Total, all-cause mortality	Placebo
Total, other adverse events	Abatacept	39	69
Total, other adverse events	Placebo	42	68
Total, serious adverse events	Abatacept	28	69
Total, serious adverse events	Placebo	26	68

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25403681	RESULT	PubMed
25779381	RESULT	PubMed

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 comparisons9

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Abatacept vs Placebo: Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response	Trial comparisons
Abatacept vs Placebo: Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response	Trial comparisons
Abatacept vs Placebo: Number of Participants With Partial Response	Trial comparisons
Week 24 Complete Response: Abatacept vs Week 24 Complete Response: Placebo: Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52	Trial comparisons
Abatacept vs Placebo: Lupus Disease Activity - Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104	Trial comparisons
Abatacept vs Placebo: Number of Participants With Complete Response	Trial comparisons
Abatacept vs Placebo: Lupus Disease Activity - Negative Anti-dsDNA	Trial comparisons
Week 24 Non-Responder: Abatacept vs Week 24 Non-Responder: Placebo: Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study	Trial comparisons
Abatacept vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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