Treatment of Renal Sarcoidosis by Methylprednisolone Bolus (CORTICOIDOSE)
This study is currently recruiting participants.
Verified November 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01652417
First received: May 16, 2012
Last updated: November 16, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Renal Sarcoidosis |
Drug: methylprednisolone bolus IV 15 mg/kg/d for 3 days. |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized, Multicentric Study Evaluating the Efficacy and the Safety of Methylprednisolone Bolus in the Treatment of Renal Sarcoidosis |
Resource links provided by NLM:
Drug Information available for:
Prednisolone
Prednisolone acetate
Prednisone
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
U.S. FDA Resources
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- Percentage of patients with a positive response defined by eGRF better than 100% compared to eGRF prior treatment or a normalization of renal function. [ Time Frame: 3 months after the beginning of the treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Efficacy (eGFR, percentage of patients with a eGRF < 60 ml/min/1.73m²) [ Time Frame: 1, 3, 6 and 12 months after the beginning of the treatment ] [ Designated as safety issue: No ]
- Extra-renal manifestations [ Time Frame: 1, 3, 6 and 12 months after the beginning of the treatment ] [ Designated as safety issue: Yes ]
- incidence of arrhythmias and cardiac conduction disease [ Time Frame: 1, 3, 6 and 12 months after the beginning of the treatment ] [ Designated as safety issue: Yes ]
- fragility fracture [ Time Frame: 1, 3, 6 and 12 months after the beginning of the treatment ] [ Designated as safety issue: Yes ]
- neuro-psychiatric troubles and infections [ Time Frame: 1, 3, 6 and 12 months after the beginning of the treatment ] [ Designated as safety issue: Yes ]
- number of renal and extra-renal relapses. [ Time Frame: 1, 3, 6 and 12 months after the beginning of the treatment ] [ Designated as safety issue: Yes ]
- Characterization of vitamin and calcium deficiencies by blood and urinary dosages [ Time Frame: 1, 3, 6 and 12 months after the beginning of the treatment ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: oral prednisone
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
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.
methylprednisolone bolus IV 15 mg/kg/d for 3 days.
Other Name: Solumédrol
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 < 50 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652417
Contacts
| Contact: Jean-Jacques Boffa, PU-PH | + 33 (0) 1 56 01 60 29 | jean-jacques.boffa@tnn.aphp.fr |
Locations
| France | |
| Service de Néphrologie et Dialyses, Hôpital Tenon | Recruiting |
| Paris, France | |
| Contact: Jean-Jacques Boffa, PU-PH | |
| Principal Investigator: Jean-Jacques Boffa, PU-PH | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01652417 History of Changes |
| Other Study ID Numbers: | P 110118, AOM 11003 |
| Study First Received: | May 16, 2012 |
| Last Updated: | November 16, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: French Data Protection Authority |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Methylprednisolone prednisone renal sarcoidosis treatment |
Additional relevant MeSH terms:
|
Sarcoidosis Lymphoproliferative Disorders Lymphatic Diseases Methylprednisolone acetate Prednisolone acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Prednisone Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013