A randomized pilot trial comparing methylprednisolone plus a cytotoxic agent versus synthetic adrenocorticotropic hormone in idiopathic membranous nephropathy.
BACKGROUND
We conducted a pilot trial to compare the effectiveness and safety of 2 different treatments in patients with membranous nephropathy and nephrotic syndrome.


METHODS
To validate the hypothesis that the 2 treatments were equivalent, patients with biopsy-proven membranous nephropathy and nephrotic syndrome were randomly assigned to methylprednisolone alternated with a cytotoxic drug every other month for 6 months (group A) or to intramuscular synthetic adrenocorticotropic hormone administered twice a week for 1 year (group B).


RESULTS
The primary outcome measure is cumulative number of remissions as a first event. Fifteen of 16 patients in group A and 14 of 16 patients in group B entered complete or partial remission as a first event. After a median follow-up of 24 months (interquartile range, 15 to 25 months), there were 4 complete remissions and 8 partial remissions in group A versus 8 complete remissions and 6 partial remissions in group B. Median proteinuria decreased from protein of 5.1 g/d (interquartile range, 4.0 to 7.3 g/d) to 2.1 g/d (interquartile range, 0.4 to 3.8 g/d; P = 0.004) in group A and 6.0 g/d (interquartile range, 4.4 to 8.5 g/d) to 0.3 g/d (interquartile range, 0.2 to 1.9 g/d; P = 0.049) in group B. Two patients from each group interrupted treatment because of side effects or inefficacy.


CONCLUSIONS
Most nephrotic patients with membranous nephropathy responded to either treatment. Proteinuria was significantly decreased with both methylprednisolone and cytotoxic agents or prolonged administration of synthetic adrenocorticotropic hormone, without significant differences between these 2 therapies.
Ponticelli
Claudio
C
Istituto Scientifico Auxologico Italiano, Milan, Italy. claudio.ponticelli@fastwebnet.it
Passerini
Patrizia
P
Salvadori
Maurizio
M
Manno
Carlo
C
Viola
Battista Fabio
BF
Pasquali
Sonia
S
Mandolfo
Salvatore
S
Messa
Piergiorgio
P
D000324:Adrenocorticotropic Hormone / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage*; D002699:Chlorambucil / Q000008:administration & dosage*; D003520:Cyclophosphamide / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D015433:Glomerulonephritis, Membranous / Q000188:drug therapy*; D006728:Hormones / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage*; D008875:Middle Aged; D009404:Nephrotic Syndrome / Q000188:drug therapy*; D010865:Pilot Projects; D011446:Prospective Studies
D018906:Antineoplastic Agents, Alkylating; D006728:Hormones; D002699:Chlorambucil; D003520:Cyclophosphamide; D000324:Adrenocorticotropic Hormone; D008775:Methylprednisolone