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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 NĂ©phrologie et Dialyses, HĂ´pital 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

Page last updated: August 23, 2015

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