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.

Humans Methylprednisolone / adverse effects Prednisone / adverse effects Prospective Studies Nephritis, Interstitial / drug therapy Sarcoidosis / drug therapy Treatment Outcome
methylprednisolone renal sarcoidosis treatment tubulointerstitial nephritis

Journal

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
ISSN: 1460-2385
Titre abrégé: Nephrol Dial Transplant
Pays: England
ID NLM: 8706402

Informations de publication

Date de publication:
31 03 2023
Historique:
received: 29 12 2021
medline: 4 4 2023
pubmed: 7 9 2022
entrez: 6 9 2022
Statut: ppublish

Résumé

We determine the benefit of pulsed methylprednisolone for improving kidney function in patients with sarcoidosis tubulointerstitial nephritis. We conducted a multicenter, prospective, randomized, open-label, controlled trial in patients with biopsy-proven acute tubulointerstitial nephritis caused by sarcoidosis at 21 sites in France. Patients were randomly assigned to receive a methylprednisolone pulse 15 mg/kg/day for 3 days, then oral prednisone (MP group) or oral prednisone 1 mg/kg/day alone (PRD group). The primary end point was a positive response at 3 months, defined as a doubling of estimated glomerular filtration rate (eGFR) compared with the eGFR before randomization. We randomized 40 participants. Baseline eGFR before PRD was 22 mL/min/1.73m2 {interquartile range [IQR], 16-44} and before MP was 25 mL/min/1.73m2 (IQR, 22-36) (P = .3). The two groups did not differ in underlying pathological lesions, including mean percentage of interstitial fibrosis and intensity of interstitial infiltrate. In the intent-to-treat population, the median eGFR at 3 months did not significantly differ between the PRD and MP groups: 45 (IQR, 34-74) and 46 (IQR, 39-65) mL/min/1.73m2. The primary end point at 3 months was achieved in 16 of 20 (80%) PRD patients and 10 of 20 (50%) MP patients (P = .0467). The eGFR was similar between the two groups after 1, 3, 6, and 12 months of treatment. For both groups, eGFR at 1 month was strongly correlated with eGFR at 12 months (P < .0001). The two groups did not differ in severe adverse events. Compared with a standard oral steroid regimen, intravenous MP may have no supplemental benefit for renal function in patients with tubulointerstitial nephritis caused by sarcoidosis.Trial Registration: ClinicalTrials.gov: NCT01652417; EudraCT: 2012-000149-11.

Sections du résumé

BACKGROUND
We determine the benefit of pulsed methylprednisolone for improving kidney function in patients with sarcoidosis tubulointerstitial nephritis.
METHODS
We conducted a multicenter, prospective, randomized, open-label, controlled trial in patients with biopsy-proven acute tubulointerstitial nephritis caused by sarcoidosis at 21 sites in France. Patients were randomly assigned to receive a methylprednisolone pulse 15 mg/kg/day for 3 days, then oral prednisone (MP group) or oral prednisone 1 mg/kg/day alone (PRD group). The primary end point was a positive response at 3 months, defined as a doubling of estimated glomerular filtration rate (eGFR) compared with the eGFR before randomization.
RESULTS
We randomized 40 participants. Baseline eGFR before PRD was 22 mL/min/1.73m2 {interquartile range [IQR], 16-44} and before MP was 25 mL/min/1.73m2 (IQR, 22-36) (P = .3). The two groups did not differ in underlying pathological lesions, including mean percentage of interstitial fibrosis and intensity of interstitial infiltrate. In the intent-to-treat population, the median eGFR at 3 months did not significantly differ between the PRD and MP groups: 45 (IQR, 34-74) and 46 (IQR, 39-65) mL/min/1.73m2. The primary end point at 3 months was achieved in 16 of 20 (80%) PRD patients and 10 of 20 (50%) MP patients (P = .0467). The eGFR was similar between the two groups after 1, 3, 6, and 12 months of treatment. For both groups, eGFR at 1 month was strongly correlated with eGFR at 12 months (P < .0001). The two groups did not differ in severe adverse events.
CONCLUSION
Compared with a standard oral steroid regimen, intravenous MP may have no supplemental benefit for renal function in patients with tubulointerstitial nephritis caused by sarcoidosis.Trial Registration: ClinicalTrials.gov: NCT01652417; EudraCT: 2012-000149-11.

Identifiants

DOI: 10.1093/ndt/gfac227 PMID: 36066903
pubmed: 36066903
pii: 6692948
doi: 10.1093/ndt/gfac227
doi:

Substances chimiques

Methylprednisolone X4W7ZR7023
Prednisone VB0R961HZT

Banques de données

ClinicalTrials.gov
['NCT01652417']
EudraCT
['2012-000149-11']

Types de publication

Randomized Controlled Trial Multicenter Study Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

961-968

Investigateurs

Papo Thomas (P)
Cottin Vincent (C)
Lionet Arnaud (L)
Chauveau Dominique (C)
Naccache Jean-Marc (N)
Hirschi Sandrine (H)
Choukroun Gabriel (C)
Simon Tabassome (S)
Admane Hakeem (A)
Berard Laurence (B)
Hummel Aurélie (H)
Vrigneaud Laurence (V)
Godeau Bertrand (G)
Juillard Laurent (J)
Dussol Bertrand (D)
Moulin Bruno (M)

Informations de copyright

© The Author(s) 2022. Published by Oxford University Press on behalf of the ERA.

Auteurs

Matthieu Mahevas (M)

Service de Médecine Interne, Centre National de Référence des Cytopénies Auto-immunes de l'adulte, Hôpital Henri Mondor, Universite Paris Est Creteil, Assistance Publique Hôpitaux de Paris, Créteil, France.

Vincent Audard (V)

Nephrology and Renal Transplantation Department, Hopital Henri Mondor, Assistance Publique-Hôpitaux de Paris, Créteil, France.
Institut National de la Santé et de la Recherche Médicale, Institut Mondor de Recherche Biomédicale, Université Paris-Est Creteil, Créteil, France.

Alexandra Rousseau (A)

Clinical Research Platform of East of Paris, Hôpital Saint Antoine, Assistance Publique-Hopitaux de Paris, Paris, France.

Alexandre Cez (A)

Nephrology Department, Sorbonne Université, Hôpital Tenon, Assistance Publique-Hopitaux de Paris, Paris, France.

Dominique Guerrot (D)

Nephrology Department, Rouen University Hospital, Normandie Université, Rouen, France.
ORCID: 0000-0002-5953-5785

David Verhelst (D)

Nephrology Department, Centre Hospitalier d'Avignon, Avignon, France.

Michel Delahousse (M)

Nephrology and Renal Transplantation Department, Hôpital Foch, Suresnes, France.

Catherine Hanrotel (C)

Nephrology, Dialysis and Renal Transplantation Department, Hôpital Universitaire de la Cavale Blanche, Brest, France.

Evangeline Pillebout (E)

Service de Néphrologie, Hôpital St-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France.

Eric Daugas (E)

Department of Nephrology, Hôpital Bichat-Claude-Bernard, Universite de Paris, Assistance Publique-Hôpitaux de Paris, Paris, France.

Evguenia Krastinova (E)

Clinical Research Platform of East of Paris, Hôpital Saint Antoine, Assistance Publique-Hopitaux de Paris, Paris, France.

Dominique Valeyre (D)

Université Sorbonne Paris Nord, Hôpital Avicenne, Assistance Publique-Hopitaux de Paris, Bobigny, France.

Jean-Jacques Boffa (JJ)

Nephrology Department, Sorbonne Université, Hôpital Tenon, Assistance Publique-Hopitaux de Paris, Paris, France.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Efficacy and safety of methylprednisolone...
questionsmedicales.fr › Composés polycycliques › Composés à cycles fusionnés › Stéroïdes › Prégnanes › Prégnadiènes › Prégnadiènetriols › Prednisolone › Méthylprednisolone › Efficacy and safety of methylprednisolone...
questionsmedicales.fr › Composés polycycliques › Composés à cycles fusionnés › Stéroïdes › Prégnanes › Prégnadiènes › Prégnadiènediols › Prednisone › Efficacy and safety of methylprednisolone...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études prospectives › Efficacy and safety of methylprednisolone...
questionsmedicales.fr › Maladies urogénitales › Maladies urologiques › Maladies du rein › Néphrite › Néphrite interstitielle › Efficacy and safety of methylprednisolone...
questionsmedicales.fr › Maladies du système immunitaire › Hypersensibilité › Hypersensibilité retardée › Sarcoïdose › Efficacy and safety of methylprednisolone...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Efficacy and safety of methylprednisolone...