作者
Marie C Hogan, Tetyana V Masyuk, Linda Page, David R Holmes III, Xujian Li, Eric J Bergstralh, Maria V Irazabal, Bohyun Kim, Bernard F King, James F Glockner, Nicholas F LaRusso, Vicente E Torres
发表日期
2012/9/1
期刊
Nephrology Dialysis Transplantation
卷号
27
期号
9
页码范围
3532-3539
出版商
Oxford University Press
简介
Background
We showed in a randomized double-blinded placebo-controlled clinical trial that octreotide long-acting repeatable depot.® (OctLAR®) for 12 months reduces kidney and liver growth in autosomal dominant polycystic kidney patients with severe polycystic liver disease (PLD) and liver growth in patients with severe isolated PLD. We have now completed an open-label extension for one additional year to assess safety and clinical benefits of continued use of OctLAR for 2 years (O→O) and examined drug effect in the placebo group who crossed over to OctLAR in Year 2 (P→O).
Methods
The primary end point was change in total liver volume (TLV) measured by magnetic resonance imaging (MRI); secondary end points were changes in total kidney volume (TKV) measured by MRI, glomerular filtration rate (GFR), quality of life (QOL), safety, vital signs and laboratory …
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MC Hogan, TV Masyuk, L Page, DR Holmes III, X Li… - Nephrology Dialysis Transplantation, 2012