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Treatment of Renal Sarcoidosis by Methylprednisolone Bolus (CORTICOIDOSE)

Primary Purpose

Renal Sarcoidosis

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

methylprednisolone bolus IV 15 mg/kg/d for 3 days.

About this trial

This is an interventional treatment trial for Renal Sarcoidosis focused on measuring Methylprednisolone, prednisone, renal sarcoidosis treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Service de Néphrologie et Dialyses, Hôpital Tenon

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

oral prednisone

methylprednisolone bolus

Arm Description

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.

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.

Outcomes

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01652417

First Posted

May 16, 2012

Last Updated

February 24, 2016

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT01652417

Brief Title

Treatment of Renal Sarcoidosis by Methylprednisolone Bolus

Acronym

CORTICOIDOSE

Official Title

Randomized, Multicentric Study Evaluating the Efficacy and the Safety of Methylprednisolone Bolus in the Treatment of Renal Sarcoidosis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Terminated

Why Stopped

insufficient recruitment

Study Start Date

October 2012 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Sarcoidosis

Keywords

Methylprednisolone, prednisone, renal sarcoidosis treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

oral prednisone

Arm Type

No Intervention

Arm Description

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.

Arm Title

methylprednisolone bolus

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

methylprednisolone bolus IV 15 mg/kg/d for 3 days.

Other Intervention Name(s)

Methylprenisolone Mylan

Intervention Description

methylprednisolone bolus IV 15 mg/kg/d for 3 days.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Efficacy (eGFR, percentage of patients with a eGRF < 60 ml/min/1.73m²)

Time Frame