Treatment of Renal Sarcoidosis by Methylprednisolone Bolus

• Status: Terminated
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Renal sarcoidosis treatment is based on steroids, but the dose and duration are unknown. Despite this treatment, most patients will have chronic kidney disease. From our previous studies, the investigators believe that high dose steroids by methylprednisolone bolus will improve patient outcome and renal function.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Acute kidney injury with estimated glomerular filtration rate (eGFR) < 60 mL/min/1,73 m2, defined by an increase of initial value > 25% or an increase of > 30 µmol/l, since at least 3 months.

• Sarcoidosis diagnostic criteria according to ATS/ERS/WASOG (Am J Respir Crit Care Med 1999)

• Renal biopsy compatible with renal sarcoidosis :

• Granulomatosis tubulo-interstitial nephropathy and extra-renal damage of histologically proved or suggestive sarcoidosis Or

• Tubulo-interstitial nephropathy without granuloma and extra-renal damage of histologically proved sarcoidosis

• Informed consent

• Patients with social security

Exclusion Criteria:

• Corticosteroids greater than 0,25 mg/kg/j prednisone equivalent

• Introduction of an immunosuppressant in the month before inclusion

• Another cause of renal granulomatosis or tubulo-interstitial nephropathy

• Isolated renal damage without extra-renal past or present damage for a sarcoidosis

• Chronic renal failure, prior sarcoidosis with eGFR < 30 mL/min/1,73 m2

• Acute renal failure from other causes. If hypercalcaemia is greater than 3 mmol/L, the correction of any dehydration will systematically salt intake, followed of renal function control before inclusion.

• Pregnancy, nursing

• Tuberculosis

• Uncontrolled sepsis

• Uncontrolled psychotic state

• Hypersensibility to methylprednisolone hemisuccinate

• Drugs prescription causing wave burst arrhythmia and/or long QT on ECG