uu.seUppsala University Publications
Change search
ReferencesLink to record
Permanent link

Direct link
Efficacy of Sotrastaurin Plus Tacrolimus After De Novo Kidney Transplantation: Randomized, Phase II Trial Results
Show others and affiliations
2013 (English)In: American Journal of Transplantation, ISSN 1600-6135, E-ISSN 1600-6143, Vol. 13, no 7, 1746-1756 p.Article in journal (Refereed) Published
Abstract [en]

Sotrastaurin, a novel immunosuppressant, blocks early T cell activation through protein kinase C inhibition. Efficacy and safety of sotrastaurin with tacrolimus were assessed in a dose-ranging non-inferiority study in renal transplant recipients. A total of 298 patients were randomized 1:1:1:1 to receive sotrastaurin 100 (n = 77; discontinued in December 2011) or 200 mg (n = 73) b.i.d. plus standard tacrolimus (sTAC; 5-12 ng/mL), sotrastaurin 300 mg (n = 75) b.i.d. plus reduced tacrolimus (rTAC; 2-5 ng/mL) or enteric-coated mycophenolic acid (MPA) plus sTAC (n = 73); all patients received basiliximab and corticosteroids. Composite efficacy failure (treated biopsy-proven acute rejection ≥ grade IA, graft loss, death or loss to follow up) rates at Month 12 were 18.8%, 12.4%, 10.9% and 14.0% for the sotrastaurin 100, 200 and 300 mg, and MPA groups, respectively. The median estimated glomerular filtration rates were 55.7, 53.3, 64.9 and 59.2 mL/min, respectively. Mean heart rates were faster with higher sotrastaurin doses and discontinuations due to adverse events and gastrointestinal adverse events were more common. Fewer patients in the sotrastaurin groups experienced leukopenia than in the MPA group (1.3-5.5% vs. 16.5%). Sotrastaurin 200 and 300 mg had comparable efficacy to MPA in prevention of rejection with no significant difference in renal function between the groups.

Place, publisher, year, edition, pages
2013. Vol. 13, no 7, 1746-1756 p.
Keyword [en]
Efficacy; enteric-coated mycophenolic acid; kidney transplantation; sotrastaurin; tacrolimus
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-199971DOI: 10.1111/ajt.12251ISI: 000320928800018PubMedID: 23668931OAI: oai:DiVA.org:uu-199971DiVA: diva2:621878
Available from: 2013-05-17 Created: 2013-05-17 Last updated: 2013-08-15Bibliographically approved

Open Access in DiVA

No full text

Other links

Publisher's full textPubMed

Search in DiVA

By author/editor
von Zur-Mühlen, Bengt
By organisation
Transplantation Surgery
In the same journal
American Journal of Transplantation
Medical and Health Sciences

Search outside of DiVA

GoogleGoogle Scholar
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 253 hits
ReferencesLink to record
Permanent link

Direct link