Clinical Trial: Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients
Study Status: Completed
Recruit Status: RECRUITING
Condition: BK Viremia; BKV DNAemia
Study Type: INTERVENTIONAL
Official Title: Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients, a Randomized Phase II/III Study, Double-blind and Placebo-controlled
Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in Kidney Transplant Recipients (KTRs).The study includes two parts.The phase II part will evaluate the safety of AntiBKV in KTRs and establish proof of concept.The phase III part will assess the efficacy of AntiBKV in KTRs.For both the phase II and phase III parts, participants will be randomized to receive either four doses of AntiBKV or four doses of…
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