Treatment of Renal Sarcoidosis by Methylprednisolone Bolus (CORTICOIDOSE)

Assistance Publique - Hôpitaux de Paris

Status: Terminated

Conditions: Renal Sarcoidosis

Treatments: Drug: methylprednisolone bolus IV 15 mg/kg/d for 3 days.

Study type: Interventional

Funder types: Other

Identifiers

NCT01652417

AOM 11003 (Other Identifier)

P 110118

Details and patient eligibility

About

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.

Full description

In a multicentric, randomized, open trial, the investigators will assess the efficacy of methylprednisolone bolus at 15mg/kg/d for 3 days before oral steroids on renal function improvement in renal sarcoidosis patients.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

oral prednisone

No Intervention group

Description:

Oral prednisone 1 mg/kg/d for 30 days and progressive tapering of steroids, to get 0,5 mg/kg/d at M3 and 0,25 mg/kg/d at M6 and 5-10 mg at M12.

methylprednisolone bolus

Experimental group

Description:

methylprednisolone bolus 15 mg/kg/d for 3 days before oral prednisone 1 mg/kg/d for 30 days and progressive tapering of steroids, to get 0,5 mg/kg/d at M3 and 0,25 mg/kg/d at M6 and 5-10 mg at M12.

Treatment:

Drug: methylprednisolone bolus IV 15 mg/kg/d for 3 days.