Treatment of Renal Sarcoidosis by Methylprednisolone Bolus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized, Multicentric Study Evaluating the Efficacy and the Safety of Methylprednisolone Bolus in the Treatment of Renal Sarcoidosis

Conditions
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Renal Sarcoidosis

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: oral prednisone<br>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. | |
| Experimental: methylprednisolone bolus<br>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. | Drug: methylprednisolone bolus IV 15 mg/kg/d for 3 days.<br>* methylprednisolone bolus IV 15 mg/kg/d for 3 days.<br>* Other names: Methylprenisolone Mylan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methylprednisolone, prednisone, renal sarcoidosis treatment