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Sotrastaurin, a Nov...
Sotrastaurin, a Novel Small Molecule Inhibiting Protein-Kinase C : Randomized Phase II Study in Renal Transplant Recipients
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Friman, S. (author)
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Arns, W. (author)
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Nashan, B. (author)
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Vincenti, F. (author)
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Banas, B. (author)
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Budde, K. (author)
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Cibrik, D. (author)
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Chan, L. (author)
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Klempnauer, J. (author)
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Mulgaonkar, S. (author)
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Nicholson, M. (author)
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- Wahlberg, Jan (author)
- Uppsala universitet,Transplantationskirurgi
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Wissing, K. -M (author)
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Abrams, K. (author)
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Witte, S. (author)
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Woodle, E. S. (author)
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(creator_code:org_t)
- Elsevier BV, 2011
- 2011
- English.
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In: American Journal of Transplantation. - : Elsevier BV. - 1600-6135 .- 1600-6143. ; 11:7, s. 1444-1455
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- Sotrastaurin, a selective protein-kinase-C inhibitor, blocks early T-cell activation through a calcineurin-independent mechanism. In this study, de novo renal transplant recipients with immediate graft function were randomized 1: 2 to tacrolimus (control, n = 44) or sotrastaurin (300 mg b.i.d.; n = 81). All patients received basiliximab, mycophenolic acid (MPA) and steroids. The primary endpoint was the composite of treated biopsy-proven acute rejection (BPAR), graft loss, death or lost to follow-up at month 3. The main safety assessment was estimated glomerular filtration rate (eGFR); modification of diet in renal disease (MDRD) at month 3. Composite efficacy failure at month 3 was higher for the sotrastaurin versus control regimen (25.7% vs. 4.5%, p = 0.001), driven by higher BPAR rates (23.6% vs. 4.5%, p = 0.003), which led to early study termination. Median (+/- standard deviation [SD]) eGFR was higher for sotrastaurin versus control at all timepoints from day 7 (month 3: 59.0 +/- 22.3 vs. 49.5 +/- 17.7 mL/min/1.73 m(2), p = 0.006). The most common adverse events were gastrointestinal disorders (control: 63.6%; sotrastaurin: 88.9%) which led to study-medication discontinuation in two sotrastaurin patients. This study demonstrated a lower degree of efficacy but better renal function with the calcineurin-inhibitor-free regimen of sotrastaurin+MPA versus the tacrolimus-based control. Ongoing studies are evaluating alternative sotrastaurin regimens.
Keyword
- Allotransplantation
- calcineurin inhibitor toxicity
- drug development
- efficacy
- immunosuppression
- mycophenolic acid
- renal function
- safety
- tacrolimus
- T-cell activation
- MEDICINE
- MEDICIN
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Friman, S.
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Arns, W.
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Nashan, B.
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Vincenti, F.
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Banas, B.
-
Budde, K.
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show more...
-
Cibrik, D.
-
Chan, L.
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Klempnauer, J.
-
Mulgaonkar, S.
-
Nicholson, M.
-
Wahlberg, Jan
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Wissing, K. -M
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Abrams, K.
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Witte, S.
-
Woodle, E. S.
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show less...
- Articles in the publication
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American Journal ...
- By the university
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Uppsala University