Search / Trial NCT00001212

Drug Therapy in Lupus Nephropathy

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Nov 3, 1999

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Systemic Lupus Erythematosus Nephrotic Syndrome Immunosuppressive Drugs Prednisone Methylprednisolone Cyclophosphamide Cyclosporine Cyclosporin A

Description

This is a phase 2 trial to evaluate the effectiveness and toxicity of immunosuppressive drug therapy in patients with membranous lupus nephropathy over a 12 month study period. Patients with renal biopsy documented membranous nephropathy will all be treated with alternate day prednisone and will be randomized to receive: a) no additional therapy (control group), b) intravenous cyclophosphamide up to 1.0 gm per m(2) body surface area every other month for 6 total doses, or c) oral cyclosporin A up to 200 mg per m(2) body surface area daily for a total of 11 months. Patients with glomerular f...

Gender

All

Eligibility 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.

Attachments

readout_NCT00001212_2024-03-02.pdf

4.5 MB

NCT00001212_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Within the firs year after starting protocol treatment

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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