Kidney Week

Abstract: TH-PO509

Efficacy and Safety of Initial Pulse Methylprednisolone Treatment in Renal Sarcoidosis: A Randomized Trial

Session Information

• CKD: Clinical Trials and Tubulointerstitial Disorders
  November 02, 2017 | Location: Hall H, Morial Convention Center
  Abstract Time: 10:00 AM - 10:00 AM

Category: Chronic Kidney Disease (Non-Dialysis)

• 305 CKD: Clinical Trials and Tubulointerstitial Disorders

Authors

• Boffa, Jean-Jacques, Tenon Hospital, AP-HP, Paris, France

Jean-Jacques Boffa,

• Mahevas, Matthieu, AP-HP, UPEC UNIVERSITY, Paris, France

Matthieu Mahevas,

• Daugas, Eric, Bichat hospital, AP-HP, Paris, France

Eric Daugas,

• Guerrot, Dominique, Rouen University Hospital, Rouen, France

Dominique Guerrot,

• Delahousse, Michel, FOCH Hospital, Suresnes, France

Michel Delahousse,

• Simon, Tabassome, Assistance Publique -Hôpitaux de Paris, Paris, France

Tabassome Simon,

• Vrigneaud, Laurence, hospital, Valenciennes , France

Laurence Vrigneaud,

• Krastinova, Evguenia, Creteil Hospital, Créteil, France

Evguenia Krastinova,

• Pillebout, Evangeline, Hopital Saint-Louis, Paris, France

Evangeline Pillebout,

• Audard, Vincent, Mondor Hospital, AP-HP, Paris, France

Vincent Audard,

• Verhelst, David, None, PARIS, France

David Verhelst,

• Valeyre, Dominique, Avicenne Hospital AP-HP, Bobigny, France

Dominique Valeyre,

Group or Team Name

• Corticoïdose Group

Background

Sarcoidosis tubulo-interstitial nephritis (STIN) induces severe renal insufficiency with poor outcome. Despite treatment with steroids, most patients develop chronic kidney disease. Pulse methylprednisolone treatment has been used to improve renal function but this therapeutic strategy has never been evaluated. We assessed whether initial pulse methylprednisolone is effective and safe at improving renal function compared to oral steroids at 3 months of follow-up.

Methods

In a multicenter randomized open control trial, in patients with proven acute sarcoidosis tubulo-interstitial nephritis, we randomly assigned forty patients with STIN to receive pulse methylprednisolone 15 mg/kg/day for three days and per os steroids afterwards (group A) or per os 1 mg/kg/d steroids from the start (group B). The primary outcome was CKD-EPI estimated glomerular filtration rate (eGFR) during the follow-up. The primary efficacy end point was the percentage of patients having a positive response at 3 months of follow-up, defined by an improvement of more than 100% of eGFR compared to eGFR before treatment or eGFR ≥ 60 ml/min/1.73m². Secondary end points included side effects of steroids.

Results

The mean age of the trial participants was 59 (45-68) years and 70% were men. Among 40 participants, only one patient was excluded for a misdiagnosis of tuberculosis. Baseline eGFR before treatment were 25(22-37) ml/min/1.73m² for group A and 22(17-40) ml/min/1.73m² for group B, p=0.3. In the intent-to-treat population, the median eGFR was 45(39-64) ml/min/1.73m² for group A and 45(34-73) ml/min/1.73m² for group B at 3 months. Patients randomized to pulse methylprednisolone were significantly less likely to achieve the primary efficacy end point: 10 of 20 (50%) vs 16 of 20 (80%), p=0.047. eGFR were similar between groups after 1 month of treatment. No participants presented cardiac arrhythmia or conduction disorder during pulse methylprednisolone. Number of adverse effects was similar between groups: 15 in group A and 14 in group B.

Conclusion

Among patients with acute STIN, pulse methylprednisolone treatment was not significantly different from oral steroids in improving renal function at three months follow-up.

Funding

• Government Support - Non-U.S.