Treatment of Renal Sarcoidosis by Methylprednisolone Bolus
Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Sarcoidosis
Intervention: methylprednisolone bolus IV 15 mg/kg/d for 3 days. (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Assistance Publique - Hôpitaux de Paris Overall contact:
Jean-Jacques Boffa, PU-PH, Phone: + 33 (0) 1 56 01 60 29, Email: jean-jacques.boffa@tnn.aphp.fr
Summary
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.
Clinical Details
Official title: Randomized, Multicentric Study Evaluating the Efficacy and the Safety of Methylprednisolone Bolus in the Treatment of Renal Sarcoidosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of patients with a positive response defined by eGRF better than 100% compared to eGRF prior treatment or a normalization of renal function.
Secondary outcome: Efficacy (eGFR, percentage of patients with a eGRF < 60 ml/min/1.73m²)Extra-renal manifestations incidence of arrhythmias and cardiac conduction disease fragility fracture neuro-psychiatric troubles and infections number of renal and extra-renal relapses. Characterization of vitamin and calcium deficiencies by blood and urinary dosages
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Jean-Jacques Boffa, PU-PH, Phone: + 33 (0) 1 56 01 60 29, Email: jean-jacques.boffa@tnn.aphp.fr
Service de Néphrologie et Dialyses, Hôpital Tenon, Paris, France; Recruiting
Jean-Jacques Boffa, PU-PH
Jean-Jacques Boffa, PU-PH, Principal Investigator
Additional Information
Starting date: October 2012
Last updated: June 12, 2015
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