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BK Viremia After Renal Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00684372
Recruitment Status : Unknown
Verified February 2009 by Karolinska University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 26, 2008
Last Update Posted : February 6, 2009
Uppsala University Hospital
Information provided by:
Karolinska University Hospital

Brief Summary:

Hypothesis: Early detection, and treatment, of BK virus infection after kidney transplantation will prevent BK virus associated kidney transplant injury.

BK virus associated nephropathy (BKVN) is estimated to cause a progressive kidney transplant injury in 1-10% of renal transplant recipients. Diagnostic and monitoring strategies for BKVN is still being developed. Detectable virus in the blood by polymerase change reaction-test (PCR) is predictive of BKVN. Additionally, PCR provides a objective estimate of the degree of infection.

If early detection and treatment of BK virus infection is effective in preventing subsequent kidney transplant injury has not been studied. However, renal injury and dysfunction develops late in the natural course of BKVN and it seems likely that screening in combination with early treatment would be beneficial for long-term transplant survival.

There is no established treatment for BK virus infection. Nevertheless, in kidney transplanted patients diagnosed with BK virus infection, immunosuppression is reduced to allow the patients own immune system to handle the virus. However, reduction of immunosuppression has not been associated with rejection. This indicate that these patients were over-immunosuppressed, predisposing them to BKVN. Therefore, to compare the degree of immunosuppression in BKVN patients (over-immunosuppressed) to other patients (not over-immunosuppressed) could yield interesting information. One possibility would be to quantify these patients specific cellular immune response to BK virus but also to other viruses (T cell reactivity).

Leflunomide (Arava) is an immunosuppressive drug, approved for the treatment of rheumatoid arthritis, and has been used in more than 300,000 patients worldwide. Furthermore, leflunomide has been used safely in humans after clinical kidney and liver transplantation for more than 300 days. In addition to leflunomide's value in preventing rejection, it has been shown to exert inhibitory effects on different viruses. Recently published pilot studies suggest that leflunomide treatment of patients with BKVN significantly reduces the amount of BK virus in blood and prevents recurrence of kidney transplant injury. At Karolinska University Hospital, leflunomide has been used for treatment of BKVN and, in some of the patients, renal function has stabilized and BK virus load has decreased significantly.

Condition or disease Intervention/treatment Phase
Terminal Renal Failure BK Virus Infection Drug: leflunomide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BK Viremia After Renal Transplantation: Screening, Early Diagnosis, Early Reduction in Immunosuppression and Treatment With Leflunomide (Arava)
Study Start Date : May 2007
Estimated Primary Completion Date : May 2009
Estimated Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Leflunomide

Intervention Details:
  • Drug: leflunomide

    Screening: If BK viremia (BK PCR >10 000 copies/ml in serum) i. Reduced immunosuppression

    1. MMF / AZA withdrawal
    2. CNI reduction

      1. Tacrolimus 5 ng/ml in serum
      2. Cyclosporin 100 ng/ml in serum
    3. Prednisolone to maintenance level

    If effective => continue

    • Stable renal function (P-Krea)
    • >50% reduction in PCR (copies/ml) at 4 weeks after diagnosis
    • Negative PCR at > 3 months after diagnosis

    If failure => add leflunomide

    • Deteriorating renal function (P-Krea) and positive PAD = BK nephropathy
    • <50% reduction in PCR at 4 weeks after diagnosis
    • Positive PCR at >3 months after diagnosis

    Leflunomide dosing:

    ii. Loading dose of 100 mgx1 PO daily for 5 days can be used or the patient can be directly started on iii. Maintenance dose (from day 1 or day 6)

    1. Starting at 20 mgx1 PO daily
    2. Thereafter adjusted between approximately 20-60 mgx1 PO daily according to serum levels of A77 1726 and the clinical situation a. Recommended level of A77 1726 >40 ug/ml

Primary Outcome Measures :
  1. Renal function (serum creatinine) [ Time Frame: 1 year after diagnosis of BK viremia ]

Secondary Outcome Measures :
  1. Incidence of BK virus associated nephropathy [ Time Frame: 1 year after diagnosis of BK viremia ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All adult patients undergoing kidney transplantation at Karolinska University Hospital

Exclusion Criteria:

  • Absence of informed consent
  • Allergy to leflunomide
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00684372

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Karolinska University Hospital
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Uppsala University Hospital
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Principal Investigator: Lars Wennberg, MD, PhD Karolinska University Hospital
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Responsible Party: Lars Wennberg, Associate Professor, Karolinska University Hospital Identifier: NCT00684372    
Other Study ID Numbers: BK study
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009
Additional relevant MeSH terms:
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Virus Diseases
Systemic Inflammatory Response Syndrome
Pathologic Processes
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs