Treatment of Renal Sarcoidosis by Methylprednisolone Bolus

NCT ID: NCT01652417

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-11-30

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.

Conditions

Renal Sarcoidosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

Other Intervention Names

Methylprenisolone Mylan

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de Néphrologie et Dialyses, Hôpital Tenon

Paris, , France

Countries

France

References

Mahevas M, Audard V, Rousseau A, Cez A, Guerrot D, Verhelst D, Delahousse M, Hanrotel C, Pillebout E, Daugas E, Krastinova E, Valeyre D, Boffa JJ; GSF French Sarcoidosis Group. Efficacy and safety of methylprednisolone pulse followed by oral prednisone vs. oral prednisone alone in sarcoidosis tubulointerstitial nephritis: a randomized, open-label, controlled clinical trial. Nephrol Dial Transplant. 2023 Mar 31;38(4):961-968. doi: 10.1093/ndt/gfac227.

Reference Type: DERIVED

PMID: 36066903 (View on PubMed)

Other Identifiers

AOM 11003

Identifier Type: OTHER

Identifier Source: secondary_id

P 110118

Identifier Type: -

Identifier Source: org_study_id