Lupus NephritisPhase 1NCT00705367
Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg
A Phase 1 study testing Abatacept in people with Lupus Nephritis, run by Bristol-Myers Squibb at 1 site in China.
Trial summary
The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland Chinese subjects with systemic lupus erythematosus (SLE) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- Aug 2008to Jul 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, at least 18 years of age, with a diagnosis of systemic lupus erythematosus (SLE) and with lupus nephritis currently stable for the last 3 months without change in treatment for lupus nephritis
- Stable renal disease
- No flaring of other organ systems in a minimum of the last 3 months
Who cannot join
- Unstable lupus nephritis and serum creatinine >3 mg/dL
- Progressive renal failure, end stage renal disease, or renal transplant requiring continuous dialysis
- Severe unstable, refractory, or progressive SLE
- History of cancer
- Participants at risk for tuberculosis
- Autoimmune disease other than SLE as main diagnosis
- Human immunodeficiency virus or herpes zoster infection
- Hepatitis-B surface antigen-positive or hepatitis C antibody-positive participants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Placebo-Controlled, Double Blind, Parallel Group Study to Evaluate the Tolerability of a Single Dose of Abatacept 30 mg/kg Via Intravenous Infusion in Chinese SLE Subjects With Lupus Nephritis
The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland Chinese subjects with systemic lupus erythematosus (SLE)
- Conditions
- Lupus Nephritis
- Being tested
- Placebo, Abatacept
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Infusion, Intravenous, single dose, Day 1
AbataceptDrug
Also called Orencia, BMS-188667
Infusion, Intravenous, 30mg/kg, single dose, Day 1
AbataceptDrug
Also called Orencia, BMS-188667
Infusion, intravenous, 10 mg/kg, administered on Days 15 and 29 followed by doses every 4 weeks until the end of the study
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Abatacept, 30 mg/kg | Active comparator | Not described Receives: Drug: Abatacept |
| Abatacept, 10 mg/kg | Other | Open-label long-term extension phase Receives: Drug: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Measured: From Day 1 of double-blind period to 1st dose of long-term period
Short-term Period: Number of Adverse Events (AEs) Related to Study Drug
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. Intensity = mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening/disabling (grade 4).
Measured: From Day 1 of double-blind period to 1st dose of long-term period
Short-term Period: MeanSystolic and Diastolic Blood Pressure
Vital sign measurements are summarized without regard to position (sitting, standing, supine).
Measured: Day 1 predose and postdose and Day 2
Short-term Period: Mean Heart Rate
Vital signs measurements are summarized without regard to position (sitting, standing, supine).
Measured: Day 1 predose and postdose and Day 2
Short-term Period: Mean Respirations Rate
Vital sign measurements are summarized without regard to position (sitting, standing, supine).
Measured: Day 1 predose and postdose and Day 2
Short-term Period: Mean Temperature
Vital sign measurements are summarized without regard to position (sitting, standing, supine).
Measured: Day 1 predose and postdose and Day 2
Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities
Laboratory tests consisted of complete blood count, chemistry, and urinalysis.
Measured: Screening and Days 1 and 2
Secondary outcomes (7)
Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs
AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Measured: Days 15 to 56 days post last dose of the long-term period
Minimum (Cmin) Plasma Concentration of Abatacept
Cmin is the minimum, or trough, concentration of a drug observed after its administration and just prior to the administration of a subsequent dose.
Measured: Days 15, 29, 85, 169, 253 and 337
Maximum (Cmax) Plasma Concentration of Abatacept
Cmax is a drug's maximum, or peak, concentration observed after its administration.
Measured: Postdosing Day 1
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests
preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. hemoglobin (g/dL): >3g/dL drop from preRX; hematocrit (%): <0.75*preRX; erythrocytes (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/L): <0.67*LLN or >1.5*ULN, or <100,000/mm^3 or if preRX<LLN, use <0.5*preRX and <100,000/mm^3; leukocytes (*10^3 c/uL): <0.75*LLN, >1.25*ULN, <0.8*preRX if preRX <LLN or >1.2*preRX if preRX >ULN; >ULN if preRX <LLN, <LLN if >ULN preRX; neutrophils+bands (*10^3 c/uL): if value <1.00*10^3 c/uL; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL; monocytes (*10^3 c/uL): if value >2000/mm^3; basophils (*10^3 c/uL): if value >400/mm^3; eosinophils (*10^3 c/uL): if value> 0.750*10^3 c/uL
Measured: Days 15 to 56 days post last dose of the long-term period
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)
preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Glucose (mg/dL): <65 or >220. Glucose, fasting(mg/dL): <0.8*LLN or >1.5* ULN; if preRX<LLN, use <0.8*preRX or >ULN; if preRX>ULN, use >2.0*preRX or <LLN. Protein, total (g/dL): <0.9*LLN or >1.1*ULN; if preRX<LLN, use 0.9*preRX or >ULN if preRX >ULN, use 1.1*preRX or <LLN. Albumin (g/dL): <0.9*LLN, or if preRX<LLN use <0.75*preRX. Uric acid (mg/dL): >1.5*ULN; if preRX>ULN use >2*preRX. Protein, urine: if missing preRX, use>=2; if >=4; if preRX=0 or 0.5, use >=2; if preRX=1, use >=3, or if preRX=2 or 3, use >= 4. Glucose, urine: if preRX missing, use >=2; if >=4, or if preRX=0 or 0.5 use >=2,or if preRX=1, use >=3, or if preRX=2 or 3 use >=4. Blood, urine: if preRX missing, use>= 2, or if >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3; if preRX=2 or 3 use >=4. WBC, urine (hpf): if missing preRX, use>= 2, or if >= 4, or if preRX =0 or 0.5 use >=2, or if preRX=1 use >=3, or if preRX=2 or 3 use >=4.
Measured: Days 15 to 56 days post last dose of the long-term period
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)
ULN=upper limit of normal; preRX=pretreatment: ALP (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; ALT (U/L): >3X*ULN, or if preRX>ULN, use >4*preRX; GGT (/L): >*ULN, or if preRX>ULN, use >3*preRX; bilirubin (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX; BUN (mg/dL):>2*preRX; sodium: <.95*LLN, >1.05*ULN, <.95* preRX if <LLN preRX, >1.05*preRX if >ULN preRX; >ULN if <LLN preRX, <LLN if >ULN preRX; potassium: chloride: calcium: phosphorous:
Measured: Days 15 to 56 days post last dose of the long-term period
Long-term Period: Number of Participants With Abatacept-specific Antibodies
Antiabatacept antibodies in human serum were assayed using a validated electrochemiluminescent immunoassay during the period of known analyte stability.
Measured: Day15 to 56 days post last dose of the long-term period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startAug 2008
- Primary completionJan 2009
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705367
- Sponsor's protocol ID
- IM101-217
- Status last verified
- Jul 2013
- First submitted
- 24 Jun 2008
- Last updated
- 30 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Liu MF, Wang CR, Lin LC, Wu CR. CTLA-4 gene polymorphism in promoter and exon-1 regions in Chinese patients with systemic lupus erythematosus. Lupus. 2001;10(9):647-9. doi: 10.1191/096120301682430249.
PubMed 11678454
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Placebo-Controlled, Double Blind, Parallel Group Study to Evaluate the Tolerability of a Single Dose of Abatacept 30 mg/kg Via Intravenous Infusion in Chinese SLE Subjects With Lupus Nephritis
- ClinicalTrials.gov ID
- NCT00705367
- Acronym / sponsor ID
- IM101-217
- Conditions
- Lupus Nephritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Jun 2008 (estimated)
- Results
- Posted 3 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland Chinese subjects with systemic lupus erythematosus (SLE)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Abatacept, 30 mg/kg | Active comparator | Drug: Abatacept |
| Abatacept, 10 mg/kg | Other | Drug: AbataceptOpen-label long-term extension phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women, at least 18 years of age, with a diagnosis of systemic lupus erythematosus (SLE) and with lupus nephritis currently stable for the last 3 months without change in treatment for lupus nephritis
- Stable renal disease
- No flaring of other organ systems in a minimum of the last 3 months
Key exclusion criteria (8 listed)
- Unstable lupus nephritis and serum creatinine >3 mg/dL
- Progressive renal failure, end stage renal disease, or renal transplant requiring continuous dialysis
- Severe unstable, refractory, or progressive SLE
- History of cancer
- Participants at risk for tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboInfusion, Intravenous, single dose, Day 1 | Drug | Placebo |
| AbataceptAlso: Orencia, BMS-188667Infusion, Intravenous, 30mg/kg, single dose, Day 1 | Drug | Abatacept, 30 mg/kg |
| AbataceptAlso: Orencia, BMS-188667Infusion, intravenous, 10 mg/kg, administered on Days 15 and 29 followed by doses every 4 weeks until the end of the study | Drug | Abatacept, 10 mg/kg |
Primary outcome
Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs
Time frame: From Day 1 of double-blind period to 1st dose of long-term period
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Short-term Period: Number of Adverse Events (AEs) Related to Study Drug
Time frame: From Day 1 of double-blind period to 1st dose of long-term period
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. Intensity = mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening/disabling (grade 4).
Short-term Period: MeanSystolic and Diastolic Blood Pressure
Time frame: Day 1 predose and postdose and Day 2
Vital sign measurements are summarized without regard to position (sitting, standing, supine).
Short-term Period: Mean Heart Rate
Time frame: Day 1 predose and postdose and Day 2
Vital signs measurements are summarized without regard to position (sitting, standing, supine).
Short-term Period: Mean Respirations Rate
Time frame: Day 1 predose and postdose and Day 2
Vital sign measurements are summarized without regard to position (sitting, standing, supine).
Short-term Period: Mean Temperature
Time frame: Day 1 predose and postdose and Day 2
Vital sign measurements are summarized without regard to position (sitting, standing, supine).
Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities
Time frame: Screening and Days 1 and 2
Laboratory tests consisted of complete blood count, chemistry, and urinalysis.
7 secondary outcomes
Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs
Time frame: Days 15 to 56 days post last dose of the long-term period
Minimum (Cmin) Plasma Concentration of Abatacept
Time frame: Days 15, 29, 85, 169, 253 and 337
Maximum (Cmax) Plasma Concentration of Abatacept
Time frame: Postdosing Day 1
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests
Time frame: Days 15 to 56 days post last dose of the long-term period
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)
Time frame: Days 15 to 56 days post last dose of the long-term period
Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)
Time frame: Days 15 to 56 days post last dose of the long-term period
Long-term Period: Number of Participants With Abatacept-specific Antibodies
Time frame: Day15 to 56 days post last dose of the long-term period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11678454Liu MF, Wang CR, Lin LC, Wu CR. CTLA-4 gene polymorphism in promoter and exon-1 regions in Chinese patients with systemic lupus erythematosus. Lupus. 2001;10(9):647-9. doi: 10.1191/096120301682430249.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abatacept in people with Lupus Nephritis, run by Bristol-Myers Squibb at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs (time frame: From Day 1 of double-blind period to 1st dose of long-term period). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00705367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2013.