A randomized, placebo‐controlled, dose‐escalation phase I/II multicenter trial of low‐dose cidofovir for BK polyomavirus nephropathy
Background BK polyomavirus‐associated nephropathy (BKPyVAN) is an important cause of allograft dysfunction and failure in kidney transplant recipients (KTRs) and there are no proven effective treatments. Case reports and in vitro data support the potential activity of cidofovir against BK polyomavir...
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| Published in | Transplant infectious disease Vol. 26; no. 6; pp. e14367 - n/a |
|---|---|
| Main Authors | , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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Denmark
Wiley Subscription Services, Inc
01.12.2024
John Wiley and Sons Inc |
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| Abstract | Background
BK polyomavirus‐associated nephropathy (BKPyVAN) is an important cause of allograft dysfunction and failure in kidney transplant recipients (KTRs) and there are no proven effective treatments. Case reports and in vitro data support the potential activity of cidofovir against BK polyomavirus (BKPyV).
Methods
We report the results of a phase I/II, double‐blind, placebo‐controlled randomized dose‐escalation trial of cidofovir in KTRs with biopsy‐confirmed BKPyVAN and estimated glomerular filtration rate ≥30 mL/min. Intravenous cidofovir (0.25 mg/kg/dose or 0.5 mg/kg/dose) or placebo was administered on days 0, 7, 21, and 35, with final follow‐up through day 49.
Results
The trial was prematurely discontinued due to slow accrual after 22 KTRs had completed the study. Cidofovir was safe and tolerated at the doses and duration studied. The proportion of subjects with any adverse event (AE) was similar between groups (9/14 [64%] in the combined cidofovir dose groups and 6/8 [75%] in the placebo group); 84% of AEs were mild. BKPyV DNAemia reduction by day 49 was similar between groups (>1 log10 reduction in (2/9 [22.2%] of 0.25 mg/kg group, 1/5 [20%] of 0.5 mg/kg group, and 2/8 [25%] of placebo group).
Conclusions
These preliminary results indicate that low‐dose cidofovir was safe and tolerated but had no significant BKPyV‐specific antiviral effect in KTRs with BKPyVAN.
In a randomized, placebo‐controlled, dose‐escalation phase I/II multicenter trial of low‐dose cidofovir for BK polyomavirus nephropathy, cidofovir was found to be safe and tolerated but demonstrated no significant BK polyomavirus‐specific antiviral effect. |
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| AbstractList | BackgroundBK polyomavirus‐associated nephropathy (BKPyVAN) is an important cause of allograft dysfunction and failure in kidney transplant recipients (KTRs) and there are no proven effective treatments. Case reports and in vitro data support the potential activity of cidofovir against BK polyomavirus (BKPyV).MethodsWe report the results of a phase I/II, double‐blind, placebo‐controlled randomized dose‐escalation trial of cidofovir in KTRs with biopsy‐confirmed BKPyVAN and estimated glomerular filtration rate ≥30 mL/min. Intravenous cidofovir (0.25 mg/kg/dose or 0.5 mg/kg/dose) or placebo was administered on days 0, 7, 21, and 35, with final follow‐up through day 49.ResultsThe trial was prematurely discontinued due to slow accrual after 22 KTRs had completed the study. Cidofovir was safe and tolerated at the doses and duration studied. The proportion of subjects with any adverse event (AE) was similar between groups (9/14 [64%] in the combined cidofovir dose groups and 6/8 [75%] in the placebo group); 84% of AEs were mild. BKPyV DNAemia reduction by day 49 was similar between groups (>1 log10 reduction in (2/9 [22.2%] of 0.25 mg/kg group, 1/5 [20%] of 0.5 mg/kg group, and 2/8 [25%] of placebo group).ConclusionsThese preliminary results indicate that low‐dose cidofovir was safe and tolerated but had no significant BKPyV‐specific antiviral effect in KTRs with BKPyVAN. In a randomized, placebo‐controlled, dose‐escalation phase I/II multicenter trial of low‐dose cidofovir for BK polyomavirus nephropathy, cidofovir was found to be safe and tolerated but demonstrated no significant BK polyomavirus‐specific antiviral effect. BK polyomavirus-associated nephropathy (BKPyVAN) is an important cause of allograft dysfunction and failure in kidney transplant recipients (KTRs) and there are no proven effective treatments. Case reports and in vitro data support the potential activity of cidofovir against BK polyomavirus (BKPyV). We report the results of a phase I/II, double-blind, placebo-controlled randomized dose-escalation trial of cidofovir in KTRs with biopsy-confirmed BKPyVAN and estimated glomerular filtration rate ≥30 mL/min. Intravenous cidofovir (0.25 mg/kg/dose or 0.5 mg/kg/dose) or placebo was administered on days 0, 7, 21, and 35, with final follow-up through day 49. The trial was prematurely discontinued due to slow accrual after 22 KTRs had completed the study. Cidofovir was safe and tolerated at the doses and duration studied. The proportion of subjects with any adverse event (AE) was similar between groups (9/14 [64%] in the combined cidofovir dose groups and 6/8 [75%] in the placebo group); 84% of AEs were mild. BKPyV DNAemia reduction by day 49 was similar between groups (>1 log reduction in (2/9 [22.2%] of 0.25 mg/kg group, 1/5 [20%] of 0.5 mg/kg group, and 2/8 [25%] of placebo group). These preliminary results indicate that low-dose cidofovir was safe and tolerated but had no significant BKPyV-specific antiviral effect in KTRs with BKPyVAN. BK polyomavirus-associated nephropathy (BKPyVAN) is an important cause of allograft dysfunction and failure in kidney transplant recipients (KTRs) and there are no proven effective treatments. Case reports and in vitro data support the potential activity of cidofovir against BK polyomavirus (BKPyV).BACKGROUNDBK polyomavirus-associated nephropathy (BKPyVAN) is an important cause of allograft dysfunction and failure in kidney transplant recipients (KTRs) and there are no proven effective treatments. Case reports and in vitro data support the potential activity of cidofovir against BK polyomavirus (BKPyV).We report the results of a phase I/II, double-blind, placebo-controlled randomized dose-escalation trial of cidofovir in KTRs with biopsy-confirmed BKPyVAN and estimated glomerular filtration rate ≥30 mL/min. Intravenous cidofovir (0.25 mg/kg/dose or 0.5 mg/kg/dose) or placebo was administered on days 0, 7, 21, and 35, with final follow-up through day 49.METHODSWe report the results of a phase I/II, double-blind, placebo-controlled randomized dose-escalation trial of cidofovir in KTRs with biopsy-confirmed BKPyVAN and estimated glomerular filtration rate ≥30 mL/min. Intravenous cidofovir (0.25 mg/kg/dose or 0.5 mg/kg/dose) or placebo was administered on days 0, 7, 21, and 35, with final follow-up through day 49.The trial was prematurely discontinued due to slow accrual after 22 KTRs had completed the study. Cidofovir was safe and tolerated at the doses and duration studied. The proportion of subjects with any adverse event (AE) was similar between groups (9/14 [64%] in the combined cidofovir dose groups and 6/8 [75%] in the placebo group); 84% of AEs were mild. BKPyV DNAemia reduction by day 49 was similar between groups (>1 log10 reduction in (2/9 [22.2%] of 0.25 mg/kg group, 1/5 [20%] of 0.5 mg/kg group, and 2/8 [25%] of placebo group).RESULTSThe trial was prematurely discontinued due to slow accrual after 22 KTRs had completed the study. Cidofovir was safe and tolerated at the doses and duration studied. The proportion of subjects with any adverse event (AE) was similar between groups (9/14 [64%] in the combined cidofovir dose groups and 6/8 [75%] in the placebo group); 84% of AEs were mild. BKPyV DNAemia reduction by day 49 was similar between groups (>1 log10 reduction in (2/9 [22.2%] of 0.25 mg/kg group, 1/5 [20%] of 0.5 mg/kg group, and 2/8 [25%] of placebo group).These preliminary results indicate that low-dose cidofovir was safe and tolerated but had no significant BKPyV-specific antiviral effect in KTRs with BKPyVAN.CONCLUSIONSThese preliminary results indicate that low-dose cidofovir was safe and tolerated but had no significant BKPyV-specific antiviral effect in KTRs with BKPyVAN. Background BK polyomavirus‐associated nephropathy (BKPyVAN) is an important cause of allograft dysfunction and failure in kidney transplant recipients (KTRs) and there are no proven effective treatments. Case reports and in vitro data support the potential activity of cidofovir against BK polyomavirus (BKPyV). Methods We report the results of a phase I/II, double‐blind, placebo‐controlled randomized dose‐escalation trial of cidofovir in KTRs with biopsy‐confirmed BKPyVAN and estimated glomerular filtration rate ≥30 mL/min. Intravenous cidofovir (0.25 mg/kg/dose or 0.5 mg/kg/dose) or placebo was administered on days 0, 7, 21, and 35, with final follow‐up through day 49. Results The trial was prematurely discontinued due to slow accrual after 22 KTRs had completed the study. Cidofovir was safe and tolerated at the doses and duration studied. The proportion of subjects with any adverse event (AE) was similar between groups (9/14 [64%] in the combined cidofovir dose groups and 6/8 [75%] in the placebo group); 84% of AEs were mild. BKPyV DNAemia reduction by day 49 was similar between groups (>1 log10 reduction in (2/9 [22.2%] of 0.25 mg/kg group, 1/5 [20%] of 0.5 mg/kg group, and 2/8 [25%] of placebo group). Conclusions These preliminary results indicate that low‐dose cidofovir was safe and tolerated but had no significant BKPyV‐specific antiviral effect in KTRs with BKPyVAN. In a randomized, placebo‐controlled, dose‐escalation phase I/II multicenter trial of low‐dose cidofovir for BK polyomavirus nephropathy, cidofovir was found to be safe and tolerated but demonstrated no significant BK polyomavirus‐specific antiviral effect. |
| Author | Gnann, John W. Wiseman, Alexander C. Rooney, James Josephson, Michelle A. Young, Jo‐Anne H. Adey, Deborah B. Whitley, Richard J. Kew, Clifton Limaye, Ajit P. Peddi, V. Ram Imlay, Hannah Samaniego‐Picota, Milagros |
| AuthorAffiliation | 11 Department of Pediatrics University of Alabama Birmingham Alabama USA 2 Department of Medicine Medical University of South Carolina University Medical Center Charleston South Carolina USA 1 Department of Internal Medicine University of Utah Salt Lake City Utah USA 12 Department of Internal Medicine University of Washington Seattle Washington USA 10 Department of Medicine University of Wisconsin Medical School Madison Wisconsin USA 7 Department of Medicine University of Alabama at Birmingham Birmingham Alabama USA 9 Department of Medicine University of California at San Francisco San Francisco California USA 8 Department of Medicine University of Minnesota Minneapolis Minnesota USA 4 Department of Transplantation California Pacific Medical Center San Francisco California USA 5 Department of Medicine University of Colorado at Denver Health Sciences Center Denver Colorado USA 3 Gilead Sciences Foster City California USA 6 Department of Medicine University of Chicago Chicago Illinois USA |
| AuthorAffiliation_xml | – name: 7 Department of Medicine University of Alabama at Birmingham Birmingham Alabama USA – name: 1 Department of Internal Medicine University of Utah Salt Lake City Utah USA – name: 8 Department of Medicine University of Minnesota Minneapolis Minnesota USA – name: 4 Department of Transplantation California Pacific Medical Center San Francisco California USA – name: 9 Department of Medicine University of California at San Francisco San Francisco California USA – name: 10 Department of Medicine University of Wisconsin Medical School Madison Wisconsin USA – name: 11 Department of Pediatrics University of Alabama Birmingham Alabama USA – name: 2 Department of Medicine Medical University of South Carolina University Medical Center Charleston South Carolina USA – name: 5 Department of Medicine University of Colorado at Denver Health Sciences Center Denver Colorado USA – name: 3 Gilead Sciences Foster City California USA – name: 12 Department of Internal Medicine University of Washington Seattle Washington USA – name: 6 Department of Medicine University of Chicago Chicago Illinois USA |
| Author_xml | – sequence: 1 givenname: Hannah orcidid: 0000-0002-3429-4655 surname: Imlay fullname: Imlay, Hannah email: hannah.imlay@hsc.utah.edu organization: University of Utah – sequence: 2 givenname: John W. surname: Gnann fullname: Gnann, John W. organization: Medical University of South Carolina University Medical Center – sequence: 3 givenname: James surname: Rooney fullname: Rooney, James organization: Gilead Sciences – sequence: 4 givenname: V. Ram surname: Peddi fullname: Peddi, V. Ram organization: California Pacific Medical Center – sequence: 5 givenname: Alexander C. surname: Wiseman fullname: Wiseman, Alexander C. organization: University of Colorado at Denver Health Sciences Center – sequence: 6 givenname: Michelle A. surname: Josephson fullname: Josephson, Michelle A. organization: University of Chicago – sequence: 7 givenname: Clifton surname: Kew fullname: Kew, Clifton organization: University of Alabama at Birmingham – sequence: 8 givenname: Jo‐Anne H. orcidid: 0000-0003-4182-341X surname: Young fullname: Young, Jo‐Anne H. organization: University of Minnesota – sequence: 9 givenname: Deborah B. surname: Adey fullname: Adey, Deborah B. organization: University of California at San Francisco – sequence: 10 givenname: Milagros surname: Samaniego‐Picota fullname: Samaniego‐Picota, Milagros organization: University of Wisconsin Medical School – sequence: 11 givenname: Richard J. orcidid: 0000-0001-9959-9276 surname: Whitley fullname: Whitley, Richard J. organization: University of Alabama – sequence: 12 givenname: Ajit P. surname: Limaye fullname: Limaye, Ajit P. email: limaye@uw.edu organization: University of Washington |
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| Copyright | 2024 The Author(s). published by Wiley Periodicals LLC. 2024 The Author(s). Transplant Infectious Disease published by Wiley Periodicals LLC. 2024. This article is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
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| Snippet | Background
BK polyomavirus‐associated nephropathy (BKPyVAN) is an important cause of allograft dysfunction and failure in kidney transplant recipients (KTRs)... BK polyomavirus-associated nephropathy (BKPyVAN) is an important cause of allograft dysfunction and failure in kidney transplant recipients (KTRs) and there... BackgroundBK polyomavirus‐associated nephropathy (BKPyVAN) is an important cause of allograft dysfunction and failure in kidney transplant recipients (KTRs)... In a randomized, placebo‐controlled, dose‐escalation phase I/II multicenter trial of low‐dose cidofovir for BK polyomavirus nephropathy, cidofovir was found to... |
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| SubjectTerms | Adult Aged Allografts Antiviral Agents - administration & dosage Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Antiviral drugs Biopsy BK virus BK Virus - physiology Case reports Cidofovir Cidofovir - administration & dosage Cidofovir - therapeutic use Cytosine - administration & dosage Cytosine - adverse effects Cytosine - analogs & derivatives Cytosine - therapeutic use Dose-Response Relationship, Drug Double-Blind Method Female Glomerular filtration rate Glomerular Filtration Rate - drug effects Humans In vitro methods and tests Kidney Diseases - virology kidney transplant Kidney transplantation Kidney Transplantation - adverse effects Male Middle Aged Nephropathy Organophosphonates - administration & dosage Organophosphonates - adverse effects Organophosphonates - therapeutic use Original Placebos Polyomavirus Infections - drug therapy Polyomavirus Infections - virology randomized controlled trial Renal failure Treatment Outcome Tumor Virus Infections - drug therapy Tumor Virus Infections - virology |
| Title | A randomized, placebo‐controlled, dose‐escalation phase I/II multicenter trial of low‐dose cidofovir for BK polyomavirus nephropathy |
| URI | https://onlinelibrary.wiley.com/doi/abs/10.1111%2Ftid.14367 https://www.ncbi.nlm.nih.gov/pubmed/39226143 https://www.proquest.com/docview/3148682217 https://www.proquest.com/docview/3100560749 https://pubmed.ncbi.nlm.nih.gov/PMC11666883 |
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