Renal Sarcoidosis Clinical Trial
— CORTICOIDOSEOfficial title:
Randomized, Multicentric Study Evaluating the Efficacy and the Safety of Methylprednisolone Bolus in the Treatment of Renal Sarcoidosis
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.
| Status | Terminated |
| Enrollment | 40 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Néphrologie et Dialyses, Hôpital Tenon | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | 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 | No | |
| Secondary | Extra-renal manifestations | 1, 3, 6 and 12 months after the beginning of the treatment | Yes | |
| Secondary | incidence of arrhythmias and cardiac conduction disease | 1, 3, 6 and 12 months after the beginning of the treatment | Yes | |
| Secondary | fragility fracture | 1, 3, 6 and 12 months after the beginning of the treatment | Yes | |
| Secondary | neuro-psychiatric troubles and infections | 1, 3, 6 and 12 months after the beginning of the treatment | Yes | |
| Secondary | number of renal and extra-renal relapses. | 1, 3, 6 and 12 months after the beginning of the treatment | Yes | |
| Secondary | Characterization of vitamin and calcium deficiencies by blood and urinary dosages | 1, 3, 6 and 12 months after the beginning of the treatment | Yes |