Status:
TERMINATED
Cidofovir in Renal Transplant Recipients With BKVN
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
BK Virus (Nephropathy)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study will look at the safety, tolerability and effectiveness of cidofovir in kidney transplant patients who have been diagnosed with BK virus nephropathy (BKVN), a viral condition that can cause...
Detailed Description
The primary objectives of this randomized, double-blind, placebo-controlled, dose-escalation study are to evaluate the safety and tolerability of 3 dose levels of cidofovir when administered to renal ...
Eligibility Criteria
Inclusion
- Aged greater than or equal to 18 years.
- Kidney or kidney/pancreas transplant recipient.
- New onset BK Virus Nephropathy (BKVN) diagnosed by a positive plasma polymerase chain reaction (PCR) assay for BK virus deoxyribonucleic acid (DNA) or by a renal biopsy demonstrating BK virus (by immunohistochemistry, electron microscopy and/or in situ hybridization) obtained as part of standard medical care within 60 days prior to receipt of first dose of study drug.
- BK virus load in plasma greater than 10,000 copies/mL within prior 21 days.
- Glomerular filtration rate greater than 30 mL/min using Levey calculations.
- Absolute neutrophil count greater than 1000/microliter \[with granulocyte colony stimulating factor (GCSF) support as necessary\].
- Women must be post-menopausal, surgically sterile or willing to use adequate contraception (barrier method with spermicide, intrauterine device, oral contraceptives, implant or other licensed hormone method) from time of study enrollment through 1 month after the last dose of study treatment. Men must be surgically sterile or willing to use contraception (barrier method with spermicide) from time of study enrollment through 3 months after the last dose of study treatment.
Exclusion
- Unable to provide valid informed consent.
- History of intolerance to cidofovir or related compounds (i.e. other nucleotide derivatives \[adefovir or tenofovir\]).
- Pregnant or breast feeding women.
- Prior treatment with cidofovir within the last 2 weeks.
- Receipt of another investigational drug with proven nephrotoxic drug interaction with cidofovir or known antipolyoma virus activity one month prior to study entry.
- Contraindication to renal biopsy (e.g., anticoagulant medication, unwilling to undergo biopsy).
- Currently receiving or anticipated to receive any of the following within 2 weeks of randomization:
- Amphotericin preparation (intravenous)
- Aminoglycosides (intravenous)
- Platinum - based chemotherapeutic agents
- NSAIDs - non steroidal anti-inflammatory drugs (aspirin given for cardioprotective treatment is acceptable up to 650 mg per oral daily)
- Foscarnet
- Pentamidine (intravenous)
- Probenecid
- Leflunomide
- Hypotony or uveitis.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00138424
Start Date
May 1 2006
End Date
April 1 2011
Last Update
March 8 2013
Active Locations (12)
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1
University of Alabama Hospital - Nephrology
Birmingham, Alabama, United States, 35249-0001
2
California Pacific Medical Center - Sutter Pacific Medical Foundation - Transplant Nephrology
San Francisco, California, United States, 94115-1932
3
University of California San Francisco Medical Center at Parnassus - Organ Transplant
San Francisco, California, United States, 94143-2204
4
University of Colorado Denver
Aurora, Colorado, United States, 80045-2541