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Treatment of Renal Sarcoidosis by Methylprednisolone Bolus (CORTICOIDOSE)

This study has been terminated.
(insufficient recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01652417
First Posted: July 30, 2012
Last Update Posted: February 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

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 ]
  • Extra-renal manifestations [ Time Frame: 1, 3, 6 and 12 months after the beginning of the treatment ]
  • incidence of arrhythmias and cardiac conduction disease [ Time Frame: 1, 3, 6 and 12 months after the beginning of the treatment ]
  • fragility fracture [ Time Frame: 1, 3, 6 and 12 months after the beginning of the treatment ]
  • neuro-psychiatric troubles and infections [ Time Frame: 1, 3, 6 and 12 months after the beginning of the treatment ]
  • number of renal and extra-renal relapses. [ Time Frame: 1, 3, 6 and 12 months after the beginning of the treatment ]
  • 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 ]

Enrollment: 40
Study Start Date: October 2012
Study Completion Date: November 2015
Primary Completion Date: November 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: Methylprenisolone Mylan

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 < 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652417


Locations
France
Service de Néphrologie et Dialyses, Hôpital Tenon
Paris, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01652417     History of Changes
Other Study ID Numbers: P 110118
AOM 11003 ( Other Identifier: Assistance Publique )
First Submitted: May 16, 2012
First Posted: July 30, 2012
Last Update Posted: February 25, 2016
Last Verified: October 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Methylprednisolone
prednisone
renal sarcoidosis treatment

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents