A randomized trial of cyclosporine in patients with steroid-resistant focal segmental glomerulosclerosis. North America Nephrotic Syndrome Study Group.

Abstract

UNLABELLED:

A randomized trial of cyclosporine in patients with steroid-resistant focal segmental glomerulosclerosis.

BACKGROUND:

A clinical trial of cyclosporine in patients with steroid-resistant focal segmental glomerulosclerosis (FSGS) was conducted. Despite the fact that it is the most common primary glomerulonephritis to progress to renal failure, treatment trials have been very limited.

METHODS:

We conducted a randomized controlled trial in 49 cases of steroid-resistant FSGS comparing 26 weeks of cyclosporine treatment plus low-dose prednisone to placebo plus prednisone. All patients were followed for an average of 200 weeks, and the short- and long-term effects on renal function were assessed.

RESULTS:

Seventy percent of the treatment group versus 4% of the placebo group (P < 0. 001) had a partial or complete remission of their proteinuria by 26 weeks. Relapse occurred in 40% of the remitters by 52 weeks and 60% by week 78, but the remainder stayed in remission to the end of the observation period. Renal function was better preserved in the cyclosporine group. There was a decrease of 50% in baseline creatinine clearance in 25% of the treated group compared with 52% of controls (P < 0.05). This was a reduction in risk of 70% (95% CI, 9 to 93) independent of other baseline demographic and laboratory variables.

CONCLUSIONS:

These results suggest that cyclosporine is an effective therapeutic agent in the treatment of steroid-resistant cases of FSGS. Although a high relapse rate does occur, a long-term decrease in proteinuria and preservation of filtration function were observed in a significant proportion of treated patients.

• Authors: D C Cattran, G B Appel, L A Hebert, L G Hunsicker, M A Pohl, W E Hoy, D R Maxwell, C L Kunis
• Journal: Kidney international (Kidney Int) Vol. 56 Issue 6 Pg. 2220-6 (Dec 1999) ISSN: 0085-2538 [Print] United States
• PMID: 10594798 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents
• Immunosuppressive Agents
• Cyclosporine
• Prednisolone

Topics

• Adult
• Aged
• Anti-Inflammatory Agents (administration & dosage)
• Biopsy
• Cyclosporine (administration & dosage, adverse effects, toxicity)
• Drug Resistance
• Drug Therapy, Combination
• Female
• Glomerulosclerosis, Focal Segmental (drug therapy, pathology)
• Humans
• Immunosuppressive Agents (administration & dosage, adverse effects, toxicity)
• Male
• Middle Aged
• Prednisolone (administration & dosage)
• Prospective Studies
• Proteinuria (drug therapy, pathology)
• Remission Induction
• Single-Blind Method
• Treatment Outcome