Cidofovir in Renal Transplant Recipients With BKVN

• Status: Terminated
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Cidofovir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.