TY  - JOUR
A1  - Lorenz, Hanns-Martin
A1  - Schmitt, Wilhelm H.
A1  - Tesar, Vladimir
A1  - Müller-Ladner, Ulf
A1  - Tarner, Ingo
A1  - Hauser, Ingeborg A.
A1  - Hiepe, Falk
A1  - Alexander, Tobias
A1  - Woehling, Heike
A1  - Nemoto, Kyuichi
A1  - Heinzel, Peter A.
T1  - Treatment of active lupus nephritis with the novel immunosuppressant 15-deoxyspergualin : an open-label dose escalation study
T2  - Arthritis Research & Therapy
N2  - Introduction: As the immunosuppressive potency of 15-deoxyspergualin (DSG) has been shown in the therapy of renal transplant rejection and Wegener's granulomatosis, the intention of this study was to evaluate the safety of DSG in the therapy of lupus nephritis (LN). Methods: Patients with histologically proven active LN after prior treatment with at least one immunosuppressant were treated with 0.5 mg/kg normal body weight/day DSG, injected subcutaneously for 14 days, followed by a break of one week. These cycles were repeated to a maximum of 9 times. Doses of oral corticosteroids were gradually reduced to 7.5 mg/day or lower by cycle 4. Response was measured according to a predefined decision pattern. The dose of DSG was adjusted depending on the efficacy and side effects. Results: 21 patients were included in this phase-I/II study. After the first DSG injection, one patient was excluded from the study due to renal failure. 5 patients dropped out due to adverse events or serious adverse events including fever, leukopenia, oral candidiasis, herpes zoster or pneumonia. 11/20 patients achieved partial (4) or complete responses (7), 8 were judged as treatment failures and one patient was not assessable. 12 patients completed all 9 cycles; in those patients, proteinuria decreased from 5.88g/day to 3.37g/day (P = 0.028), Selena-SLEDAI decreased from 17.6 to 11.7. In 13/20 patients, proteinuria decreased by at least 50%; in 7 patients to less than 1g/day. Conclusions: Although the number of patients was small, we could demonstrate that DSG provides a tolerably safe treatment for LN. The improvement in proteinuria encourages larger controlled trials.
Y1  - 2011
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/3530
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30-93229
SN  - 1465-9913
SN  - 1478-6362
SN  - 1478-6354
N1  - © 2011 Lorenz et al. ; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
VL  - 13
IS  - 2, R36
SP  - 1
EP  - 12
PB  - BioMed Central
CY  - London
ER  -