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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00001212
Date of registration: 03/11/1999
Prospective Registration: No
Primary sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Public title: Drug Therapy in Lupus Nephropathy
Scientific title: Immunosuppressive Drug Therapy in Membranous Lupus Nephropathy
Date of first enrolment: November 1986
Target sample size: 45
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00001212
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Key inclusion & exclusion criteria

INCLUSION CRITERIA - All patients admitted to the study must satisfy each of the following
criteria:

Ability to provide informed consent to all aspects of the study after full information is
provided.

SLE as defined by the presence of at least 4 criteria established by the American
Rheumatism Association.

Age 12 years or older.

Membranous lupus nephropathy manifested by 2 or more grams per day of proteinuria in the
absence of infection or recognized non-lupus renal disease. A renal biopsy must reveal
typical membranous lupus nephropathy by light microscopy. Immune deposits must be
predominately sub-epithelial and/or intramembranous in location by electron microscopy.

EXCLUSION CRITERIA - Patients with any one of the following conditions will be excluded:

Medication history of:

- cytotoxic drugs or cyclosporin A for more than 2 weeks during the 10 week period
prior to study entry.

- cytotoxic drug therapy or cyclosporin A for more than 10 weeks at anytime in the
past.

- cytotoxic drug therapy or cyclosporin A during the 30 day period prior to study
entry.

- requirement of corticosteroids in doses greater than 20 mg/m(2)/day of prednisone (or
equivalent) for control of extrarenal disease at the time of study entry.

Active acute or chronic infection requiring antimicrobial therapy, or serious viral
infection (eg. hepatitis, herpes zoster).

Pregnant females, nursing mothers, or females not practicing birth control.

Patients with a single functioning kidney.

Pre-existent malignancy.

Insulin-treated diabetes mellitus.

GFR less than 25 ml/min/1.73m(2) BSA.

Known toxicity to cyclophosphamide.

Positive tests for HIV infection.

Furthermore, patients with any one of the following conditions (related to the use of
cyclosporin A) will be excluded from randomization within renal function group 2
(Glomerular filtration rate greater than 66 ml/min/1.73m(2)):

- Renal biopsy revealing global sclerosis of greater than 50 percent of glomeruli,
severe tubular atrophy, or severe interstitial fibrosis.

- Persistently abnormal and unexplained liver function abnormalities (defined as
elevated transaminases, bilirubin, or alkaline phosphatase twice the upper limit of
normal for at least 1 month) or evidence of active viral hepatitis.

- Hypertension difficult to control or uncontrollable with conventional
anti-hypertensive regimens.

- Documented coronary artery disease.

- Convulsive disorders.



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Nephrotic Syndrome
Systemic Lupus Erythematosus
Intervention(s)
Drug: cyclophosphamide
Drug: cyclosporin A
Drug: prednisone
Primary Outcome(s)
Time to complete or partial remission of proteinuria. [Time Frame: Within the firs year after starting protocol treatment]
Secondary Outcome(s)
Adverse Effects [Time Frame: For the duration of extended follow-up starting at the beginning of protocol treatment]
Change in glomerular filtration rate [Time Frame: One year]
Time to relapse of nephritic syndrome [Time Frame: For the duration of extended follow-up starting at the end of the 12-month protocol treatment period]
Secondary ID(s)
86-DK-0204
860204
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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