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Completed

NCT Number: NCT00705367

Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg

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)

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Key information

Conditions

Lupus Nephritis Autoimmune Diseases Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Male Urogenital Diseases Nephritis Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Shanghai, Shanghai Municipality, 200001, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Placebo

Drug

Infusion, Intravenous, single dose, Day 1

Abatacept

Drug

Infusion, Intravenous, 30mg/kg, single dose, Day 1

Other names: Orencia, BMS-188667

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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.

Secondary outcomes

  1. 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

    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.

  2. Minimum (Cmin) Plasma Concentration of Abatacept

    Time frame: Days 15, 29, 85, 169, 253 and 337

    Cmin is the minimum, or trough, concentration of a drug observed after its administration and just prior to the administration of a subsequent dose.

  3. Maximum (Cmax) Plasma Concentration of Abatacept

    Time frame: Postdosing Day 1

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

  4. 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

    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

  5. 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

    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.

  6. 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

    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:

  7. Long-term Period: Number of Participants With Abatacept-specific Antibodies

    Time frame: Day15 to 56 days post last dose of the long-term period

    Antiabatacept antibodies in human serum were assayed using a validated electrochemiluminescent immunoassay during the period of known analyte stability.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Jun 26, 2008
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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