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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

China1 site

  • Local Institution

    Shanghai, Shanghai Municipality, 200001

Other trials in China

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 groups in NCT00705367
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
Abatacept, 30 mg/kgActive comparatorNot described
Receives: Drug: Abatacept
Abatacept, 10 mg/kgOtherOpen-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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)

  1. 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

  2. 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

  3. Maximum (Cmax) Plasma Concentration of Abatacept

    Cmax is a drug's maximum, or peak, concentration observed after its administration.

    Measured: Postdosing Day 1

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted26 Jun 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionJan 2009
  4. Study completionJul 2011

Resources

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)
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
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

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.

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