Treatment of Renal Sarcoidosis by Methylprednisolone Bolus
Not Applicable
Terminated
- Conditions
- Renal Sarcoidosis
- Interventions
- Registration Number
- NCT01652417
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description methylprednisolone bolus methylprednisolone bolus IV 15 mg/kg/d for 3 days. 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.
- Primary Outcome Measures
Name Time Method Percentage of patients with a positive response defined by eGRF better than 100% compared to eGRF prior treatment or a normalization of renal function. 3 months after the beginning of the treatment
- Secondary Outcome Measures
Name Time Method Efficacy (eGFR, percentage of patients with a eGRF < 60 ml/min/1.73m²) 1, 3, 6 and 12 months after the beginning of the treatment Extra-renal manifestations 1, 3, 6 and 12 months after the beginning of the treatment incidence of arrhythmias and cardiac conduction disease 1, 3, 6 and 12 months after the beginning of the treatment fragility fracture 1, 3, 6 and 12 months after the beginning of the treatment neuro-psychiatric troubles and infections 1, 3, 6 and 12 months after the beginning of the treatment number of renal and extra-renal relapses. 1, 3, 6 and 12 months after the beginning of the treatment Characterization of vitamin and calcium deficiencies by blood and urinary dosages 1, 3, 6 and 12 months after the beginning of the treatment
Trial Locations
- Locations (1)
Service de Néphrologie et Dialyses, Hôpital Tenon
🇫🇷Paris, France