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| ID | Type | Description | Link |
|---|---|---|---|
| AOM 11003 | Other Identifier | Assistance Publique |
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insufficient recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral prednisone | No Intervention | 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 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylprednisolone bolus IV 15 mg/kg/d for 3 days. | Drug | methylprednisolone bolus IV 15 mg/kg/d for 3 days. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Néphrologie et Dialyses, Hôpital Tenon | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36066903 | Derived | Mahevas M, Audard V, Rousseau A, Cez A, Guerrot D, Verhelst D, Delahousse M, Hanrotel C, Pillebout E, Daugas E, Krastinova E, Valeyre D, Boffa JJ; GSF French Sarcoidosis Group. Efficacy and safety of methylprednisolone pulse followed by oral prednisone vs. oral prednisone alone in sarcoidosis tubulointerstitial nephritis: a randomized, open-label, controlled clinical trial. Nephrol Dial Transplant. 2023 Mar 31;38(4):961-968. doi: 10.1093/ndt/gfac227. |
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| 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 |