Cidofovir in Renal Transplant Recipients With BKVN
Stopped early · Phase 1/Phase 2 · Has a placebo group
Conditions studied: BK Virus (Nephropathy)
In brief
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 patients to reject transplanted kidneys. Up to 48 adult (age 18 years and older) kidney or pancreas transplant recipients with newly diagnosed BKVN will receive 1 of 3 cidofovir dose levels or placebo (non medicated substance) to identify the maximum tolerated dose. Dosing will be administered intravenously (by a tube running into a blood vessel). In addition to the screening visit, volunteers will actively participate for approximately 8-10 weeks with a single follow up phone call at 4 months. Blood samples, urine samples, eye exams and physical exams are included in study procedures.
Key facts
- Study ID
- NCT00138424
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 22
- Starts
- 2006-05-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2013-03-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Alabama Hospital - Nephrology — Birmingham, Alabama, United States
- California Pacific Medical Center - Sutter Pacific Medical Foundation - Transplant Nephrology — San Francisco, California, United States
- University of California San Francisco Medical Center at Parnassus - Organ Transplant — San Francisco, California, United States
- University of Colorado Denver — Aurora, Colorado, United States
- Northwestern University - Comprehensive Transplant Center — Chicago, Illinois, United States
- The University of Chicago Medical Center - Kindney Trasnplant - Nephrology — Chicago, Illinois, United States
- University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine — Minneapolis, Minnesota, United States
- Mayo Clinic, Rochester - Infectious Diseases — Rochester, Minnesota, United States
- Dartmouth-Hitchcock Medical Center - Infectious Disease — Lebanon, New Hampshire, United States
- Dallas Nephrology Associates - Dallas Transplant Institute — Dallas, Texas, United States
- University of Washington - Medicine — Seattle, Washington, United States
- University of Wisconsin Hospital and Clinics - Clinical Science Center - Nephrology — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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