Clinical trial NCT01652417: Treatment of Renal Sarcoidosis by Methylprednisolone Bolus
Official title: Randomized, Multicentric Study Evaluating the Efficacy and the Safety of Methylprednisolone Bolus in the Treatment of Renal Sarcoidosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Renal Sarcoidosis
Keywords: Methylprednisolone
prednisone
renal sarcoidosis treatment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-07-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of patients with a positive response defined by eGRF better than 100% compared to eGRF prior treatment or a normalization of renal function.
timeFrame: 3 months after the beginning of the treatment
Secondary outcomes:
measure: Efficacy (eGFR, percentage of patients with a eGRF < 60 ml/min/1.73m²)
timeFrame: 1, 3, 6 and 12 months after the beginning of the treatment
measure: Extra-renal manifestations
timeFrame: 1, 3, 6 and 12 months after the beginning of the treatment
measure: incidence of arrhythmias and cardiac conduction disease
timeFrame: 1, 3, 6 and 12 months after the beginning of the treatment
measure: fragility fracture
timeFrame: 1, 3, 6 and 12 months after the beginning of the treatment
measure: neuro-psychiatric troubles and infections
timeFrame: 1, 3, 6 and 12 months after the beginning of the treatment
measure: number of renal and extra-renal relapses.
timeFrame: 1, 3, 6 and 12 months after the beginning of the treatment
measure: Characterization of vitamin and calcium deficiencies by blood and urinary dosages
timeFrame: 1, 3, 6 and 12 months after the beginning of the treatment
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Néphrologie et Dialyses, Hôpital Tenon
Study officials:
References:
citation: 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.