Renal Sarcoidosis
Conditions
Keywords
Methylprednisolone, prednisone, renal sarcoidosis treatment
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.
Interventions
DRUGmethylprednisolone bolus IV 15 mg/kg/d for 3 days.
methylprednisolone bolus IV 15 mg/kg/d for 3 days.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| fragility fracture | 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 |
| 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 |
Countries
France
Outcome results
None listed