Treatment of Renal Sarcoidosis by Methylprednisolone Bolus (CORTICOIDOSE)

This study is currently recruiting participants.
Verified March 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01652417
First received: May 16, 2012
Last updated: March 4, 2014
Last verified: March 2014
  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:


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: September 2015
Estimated Primary Completion Date: December 2014 (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

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 < 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
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: March 4, 2014
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 April 17, 2014