BK PolyomavirusPhase 2NCT00104338
Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy
A Phase 2 study testing FK778 in people with BK Polyomavirus and Kidney Diseases, run by Astellas Pharma Inc at 21 sites in United States.
Trial summary
The purpose of this study is to assess the safety and effectiveness of a new oral immunosuppressant agent compared to standard care in renal transplant patients diagnosed with BK nephropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BK Polyomavirus, Kidney Diseases
- What is being tested?
- FK778
- How many people
- 45 participants
- Where
- 21 sitesUnited States
- Study dates
- Jan 2005to Aug 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal transplant recipient with newly diagnosed BK nephropathy.
Who cannot join
- Previous treatment for BK nephropathy
- Organ transplant other than kidney
- Uncontrolled concomitant infection other than BK nephropathy
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Study site
Atlanta, Georgia, 30322
Study site
Baltimore, Maryland, 21287
Study site
Chicago, Illinois, 60612
Study site
Chicago, Illinois, 60637
Study site
Cincinnati, Ohio, 45267
Study site
Denver, Colorado, 80262
Study site
Durham, North Carolina, 22710
Study site
Fairfax, Virginia, 22031
Study site
Gainesville, Florida, 32610
Study site
Harrisburg, Pennsylvania, 17104
Study site
Jacksonville, Florida, 32216
Study site
Los Angeles, California, 90057
Study site
Los Angeles, California, 90095
Study site
Memphis, Tennessee, 38014
Study site
New Brunswick, New Jersey, 08901
Study site
Salt Lake City, Utah, 84132
Study site
San Diego, California, 92123
Study site
San Francisco, California, 94115
Study site
San Francisco, California, 94143
Study site
Washington D.C., District of Columbia, 20010
Study site
Wichita, Kansas, 67214
About this study
Official title: A Phase 2, Proof of Concept, Randomized, Open-label, Two-arm, Parallel Group, Multi-center Study to Assess the Efficacy and Safety of FK778 Compared With Standard Care in Renal Transplant Recipients With Untreated BK Nephropathy
The purpose of this study is to assess the safety and effectiveness of a new oral immunosuppressant agent compared to standard care in renal transplant patients diagnosed with BK nephropathy.
Read the detailed description
The purpose of this study is to assess the efficacy and safety of FK778 compared with standard care in renal transplant recipients with newly diagnosed and untreated BK nephropathy.
- Conditions
- BK Polyomavirus, Kidney Diseases
- Being tested
- FK778
- Keywords
- Investigational Therapies, Treatment Effectiveness, Treatment Efficacy, Immunosuppressant, BK Nephropathy, Polyomavirus, BK, Human Polyomavirus BK, Polyomavirus hominis 1
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FK778Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in urine BK viral load
Secondary outcomes (3)
Change from baseline in plasma BK viral load
Change from baseline in renal function as measured by serum creatinine (SCr) and creatinine clearance (CrCl) at month 6 or at the end of therapy, whichever is earlier
Change from baseline in renal histology measured by Drachenberg criteria at month 6 or at the end of therapy, whichever is earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2005 (estimated)
- Study startJan 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BK PolyomavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104338
- Sponsor's protocol ID
- 04-0-196
- Status last verified
- Jun 2012
- First submitted
- 24 Feb 2005
- Last updated
- 7 Jun 2012
- Results posted
- No
Publications
Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
PubMed 39382091
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Proof of Concept, Randomized, Open-label, Two-arm, Parallel Group, Multi-center Study to Assess the Efficacy and Safety of FK778 Compared With Standard Care in Renal Transplant Recipients With Untreated BK Nephropathy
- ClinicalTrials.gov ID
- NCT00104338
- Acronym / sponsor ID
- 04-0-196
- Conditions
- BK Polyomavirus, Kidney Diseases
- Keywords
- Investigational Therapies, Treatment Effectiveness, Treatment Efficacy, Immunosuppressant, BK Nephropathy, Polyomavirus, BK, Human Polyomavirus BK, Polyomavirus hominis 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 45 participants
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Jan 2005
- Study completion
- Aug 2006 (actual)
- First posted
- 25 Feb 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and effectiveness of a new oral immunosuppressant agent compared to standard care in renal transplant patients diagnosed with BK nephropathy.
Detailed description
The purpose of this study is to assess the efficacy and safety of FK778 compared with standard care in renal transplant recipients with newly diagnosed and untreated BK nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Renal transplant recipient with newly diagnosed BK nephropathy.
Key exclusion criteria (3 listed)
- Previous treatment for BK nephropathy
- Organ transplant other than kidney
- Uncontrolled concomitant infection other than BK nephropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FK778 | Drug | – |
Primary outcome
Change from baseline in urine BK viral load
3 secondary outcomes
Change from baseline in plasma BK viral load
Change from baseline in renal function as measured by serum creatinine (SCr) and creatinine clearance (CrCl) at month 6 or at the end of therapy, whichever is earlier
Change from baseline in renal histology measured by Drachenberg criteria at month 6 or at the end of therapy, whichever is earlier
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
- Derived from this study: PubMed 39382091Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
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TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
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A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
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Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
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ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FK778 in people with BK Polyomavirus and Kidney Diseases, run by Astellas Pharma Inc at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in urine BK viral load. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00104338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2012.