Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Safety and Efficacy Trial of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease
Brief Summary: The purpose of this study is to determine whether LJP 394 (abetimus sodium) is safe and effective in delaying and reducing renal flares in patients with lupus nephritis.


Options:
A: Inclusion Criteria:

* Men and women, between the ages of 18 and 70 years of age;
* Body mass index from 18 to 40 kg/m2 \[Body Weight (kg)/Height2 (m2)\] at screening;
* Diagnosis of SLE at least 6 months before randomization, including a positive antinuclear antibodies (ANA) during screening; if screening ANA is negative, documented historical ANA with a titer of at least 1:80 will be acceptable;
* Any concurrent SLE pharmacologic regimen (including mycophenolate mofetil, azathioprine, leflunomide, methotrexate, and anti-malarials) must be stable for at least 30 days before randomization;
* Prednisone ≤ 20 mg/day (or equivalent) is permitted; one increase or one decrease of ≤ 5 mg/day prednisone equivalent will be allowed within 30 days before randomization;

Additional inclusion criteria for Part B:

- Active SLE with GN with no other apparent cause, defined by the following: Renal biopsy evidence (within 18 months) of nephritis using the WHO or International Society of Nephrology (ISN)/Renal Pathology Society (RPS) classification of SLE with GN (Class III or IV); Urine protein/creatinine ratio (UP/Cr) \> 1 or 24 hour urine protein \> 1g after at least 12 weeks of treatment with mycophenolate mofetil (at least 1.5 grams/day) or azathioprine (at least 100 mg orally per day); Superimposed membranous changes are allowed for those with Class III or Class IV SLE with GN;

- Prednisone ≤ 20 mg/day (or equivalent) at the time of randomization.

Exclusion Criteria:

* Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would, by its progressive nature and/or severity, interfere with the study evaluation, completion and/or procedures per the investigator's discretion;
* Creatinine clearance within the screening period of less than 50 mL/min as calculated by the Cockcroft-Gault method
* Signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization, or recent history of repeated infections;
* Underlying condition other than SLE or being on allowed immunosuppressants that predisposes one to infections
* Prior use of the following agents:
* Administration of an investigational biologic agent that primarily targets the immune system
* Administration of cyclosporine, tacrolimus, sirolimus, IV immunoglobulin, and/or plasmapheresis within 3 months of randomization;
* Administration of oral or IV cyclophosphamide (or any other alkylating agent) within 12 months (Part A) or 3 months (Part B) of randomization;
* History of ethanol or drug abuse within the last one year prior to randomization;

Additional exclusion criteria for Part B:

* Rapidly progressive GN (defined as a doubling of serum creatinine within the past 3 months);
* Evidence of significant chronicity, defined as:

\> 50% glomeruli with sclerosis or \> 50% interstitial fibrosis on renal biopsy; or International Society of Nephrology (ISN)/Renal Pathology Society (RPS) 2003 Class III (C), IV-S (C) or IV-G (C).
B: Inclusion Criteria:

1. Patients who fulfill at least 4 of the ACR criteria for SLE
2. Age \>= 18 years
3. Biopsy proven active lupus glomerulonephritis (ISN/RPS class III/IV/V)
4. Serum creatinine \< 200 umol/L at the time of randomization

Exclusion Criteria:

1. Patients who refuse to be randomized for treatment
2. Patients who prefer treatment with conventional agents such as oral or intravenous CYC for various reasons
3. Serum creatinine \>= 200 umol/L at the time of randomization
4. Patients without renal biopsy or those who have lupus nephritis ISN/RPS class I,II,VI
5. Patients who are pregnant or plan for pregnancy within 12 months after randomization
C: Inclusion Criteria:

1. Female patients with a diagnosis of systemic lupus erythematosus (SLE) according to the criteria of American Rheumatic Association, 1982, aged between 12-50 years, with score of SLE-DAI (Disease Active Index) of more than 12 (not including class V LN).
2. Patients diagnosed according to ISN/RPS 2003 classification criteria: class Ⅲ, Ⅳ, Ⅳ + Ⅴ, Ⅲ + Ⅴ LN by renal biopsy within 3 months, CI\< 4，Scr\< 3 mg/dl.
3. Patients with a proteinuria ≥ 1.5 g/24h, or active urine sediment.
4. Patients who signed written informed consent forms (patients less than 18 years old with their parents/legal representative' signatures), and have given their consent to follow all study procedures and follow-ups.

Exclusion Criteria:

1. Patients who have received treatment of cytotoxic drugs such as cyclophosphamide (CTX), cyclosporine A for more than 1 week within three months.
2. Patients with serum creatinine ≥ 3 mg/dl（265 μmol/L).
3. Patients with severe infection or central nervous system symptoms.
4. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
5. Patients who have abnormal blood glucose, with a fasting blood glucose \> 6.2 mmol/L or post meal blood glucose \> 11.2 mmol/L.
6. Patients who are pregnant or lactating.
7. Patients who are known to be allergic to a macrolide.
D: Inclusion Criteria

* Diagnosed with SLE
* Historical evidence of SLE renal disease
* Elevated levels of dsDNA antibodies
* Weight of 40 kg or greater

Exclusion Criteria

* Active SLE renal disease
* Use of certain anti-inflammatory or cytotoxic therapies or therapeutic interventions during the months immediately before dosing
* Clinical laboratory test values outside of certain limits
* Malignant disease or immunodeficiency syndrome
* Acute or chronic infections
* History of serious heart disease

Answer: D