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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT00001676
Date of registration: 03/11/1999
Prospective Registration: No
Primary sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Public title: Cyclophosphamide and Fludarabine to Treat Lupus Nephritis
Scientific title: Combination of Cyclophosphamide and Fludarabine for Lupus Nephritis: Tolerance, Toxicity, Efficacy and Effects on B and T Lymphocyte Regeneration
Date of first enrolment: January 1998
Target sample size: 15
Recruitment status: Completed
Study type:  Interventional
Study design:  Endpoint Classification: Safety Study, Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
United States
Key inclusion & exclusion criteria

Patients must be 18 years of age or older and able to provide informed consent.

Patients must have at least 4 criteria for SLE as defined by the American Rheumatism
Association (ARA).

Active glomerulonephritis with:

Renal biopsy within 1 year with class III or class IV active lupus nephritis, AND;

Abnormal urine analysis:

Greater than 10 RBC/hpf and cellular (RBC, WBC or mixed) casts, OR;

Greater than 10 RBC/hpf and proteinuria greater than 2 g/day, OR;

Proteinuria greater than 3.5 g/day.

No patients with severe proliferative lupus nephritis: a. very active renal histology
with crescents or necrosis in more than 25% of glomeruli; or b. rapidly progressive
glomerulonephritis (doubling of serum creatinine in less than or equal to 3 months); or c.
severe impairment of renal function Cr greater than 2.5 mg/dL or GFR less than 50 mL/min
measured by inulin clearance.

Patient has not had previous immunosuppressive therapy:

Patients must not be receiving azathioprine, cyclosporine, methotrexate. Patients
receiving these drugs will be eligible only if these drugs are discontinued and after a
waiting period of greater than or equal to 4 weeks;

Patients must not be receiving cyclophosphamide:

Greater than 3 pulses (maximum 1 g/m(2)/pulse) within the last 12 months or since last
renal biopsy showing active disease; OR

greater than 6 pulses ever.

Patients must not have had pulse therapy with glucocorticoids or any experimental therapy
during the 4 weeks before study entry.

Patients who need at study entry oral corticosteroids in dosages greater than 0.5
mg/kg/day of predisone to control extrarenal disease are not eligible.

Patients with active or chronic infection are not eligible.

Patients who are pregnant, breast-feeding or using inadequate birth control are not

Patients who have poorly controlled diabetes mellitus or with evidence of end-organ damage
are not eligible.

No history of cerebrovascular accident, seizures within the last 5 years or chronic
neurologic disease.

No history of malignancy other than squamous cell and/or basal carcinoma of the skin.

No confounding medical illness that in the judgment of investigators would pose added risk
for study participants such as:

Unstable coronary artery disease, cardiomyopathy or dysrhythmia requiring therapy;

Pulmonary disease (PFTs less 70% of predicted value or DLCO less than 60%), or;

Hematologic disease (Hb less than 8 mg/dL, platelets less than 100,000 micro liters or WBC
less than 2,500/micro liters.

Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Lupus Nephritis
Systemic Lupus Erythematosus
Drug: SQ Fludarabine
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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