Disease Due to BK PolyomavirusBKNCT00610961
Induction Related BK Viremia in Renal Transplant Patients
An observational study of Disease Due to BK Polyomavirus and Transplantation Infection, run by University of Florida at 1 site in United States.
Trial summary
The increase immunosuppression in our transplant population has led to an unacceptable rate of patients at risk for BK virus nephropathy. Reducing induction immunosuppression by switching from Thymoglobulin to Simulect will reduce the incidence of serum positivity for BK by PCR. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Disease Due to BK Polyomavirus, Transplantation Infection, Disorder Related to Transplantation
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Nov 2009
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: de novo renal or renal/pancrease transplant patients
Who may be able to join
- De novo transplant
- Aged 18-75
Who cannot join
- Serious medical condition which, in the opinion of the Principal Investigator, might interfere with the subject's ability to successfully complete the protocol.
- Any medical condition which, in the opinion of the Principal Investigator, might compromise the safety of the subject in participating in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Induction Agent Effect on BK Viremia in Renal and Pancreas Transplant Patients
The increase immunosuppression in our transplant population has led to an unacceptable rate of patients at risk for BK virus nephropathy. Reducing induction immunosuppression by switching from Thymoglobulin to Simulect will reduce the incidence of serum positivity for BK by PCR.
Read the detailed description
Our standard of care has been changed from Thymoglobulin to Simulect and now patients were enrolled in this observational trial to gather data on their outcomes related to BK viremia and rejection rates. Two groups of patients were compared.
Retrospective (historical or control) group of subjects: patients who had received a kidney transplant and were inducted with Thymoglobulin prior to study initiation.
Prospective group of subjects: patients who is scheduled to receive kidney transplant and will be inducted with Simulect (Basiliximab).
Inductions in both groups was/is Standard of Care at a time of treatment.
- Conditions
- Disease Due to BK Polyomavirus, Transplantation Infection, Disorder Related to Transplantation
- Keywords
- BK Polyomavirus, Transplantation, Kidney, Transplantation, Pancreas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Basiliximab (Simulect) Induction | Prospective group: patients are scheduled to receive a kidney transplant; and will receive Simulect®, Myfortic® and Prograf® with or without steroids according to routine care (Standard of Care). | |
| Thymoglobulin Induction | Retrospective (historical or control) group: patients have already received a kidney transplant and were treated with Thymoglobulin®, Myfortic®, and Prograf® with or without steroids. This treatment was Standard of Care at a time of transplant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BK Virus Viremia titer, >400 copies by Polymerase Chain Reaction (PCR)
BKVV (BK Visus Viremia) titer is measured by PCR at 1, 3,6,9 and 12 month time points.
Measured: One year
Secondary outcomes (1)
Incidence of Acute Rejection of Transplanted Kidney
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionApr 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease Due to BK PolyomavirusStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Herwig-Ulf Meier-Kriesche, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610961
- Sponsor's protocol ID
- 20071016
- Acronym
- BK
- Status last verified
- Sep 2011
- First submitted
- 24 Jan 2008
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Induction Agent Effect on BK Viremia in Renal and Pancreas Transplant Patients
- ClinicalTrials.gov ID
- NCT00610961
- Acronym / sponsor ID
- BK / 20071016
- Conditions
- Disease Due to BK Polyomavirus, Transplantation Infection, Disorder Related to Transplantation
- Keywords
- BK Polyomavirus, Transplantation, Kidney, Transplantation, Pancreas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Oct 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 8 Feb 2008 (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 increase immunosuppression in our transplant population has led to an unacceptable rate of patients at risk for BK virus nephropathy. Reducing induction immunosuppression by switching from Thymoglobulin to Simulect will reduce the incidence of serum positivity for BK by PCR.
Detailed description
Our standard of care has been changed from Thymoglobulin to Simulect and now patients were enrolled in this observational trial to gather data on their outcomes related to BK viremia and rejection rates. Two groups of patients were compared.
Retrospective (historical or control) group of subjects: patients who had received a kidney transplant and were inducted with Thymoglobulin prior to study initiation.
Prospective group of subjects: patients who is scheduled to receive kidney transplant and will be inducted with Simulect (Basiliximab).
Inductions in both groups was/is Standard of Care at a time of treatment.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basiliximab (Simulect) Induction | – | –Prospective group: patients are scheduled to receive a kidney transplant; and will receive Simulect®, Myfortic® and Prograf® with or without steroids according to routine care (Standard of Care). |
| Thymoglobulin Induction | – | –Retrospective (historical or control) group: patients have already received a kidney transplant and were treated with Thymoglobulin®, Myfortic®, and Prograf® with or without steroids. This treatment was Standard of Care at a time of transplant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- de novo renal or renal/pancrease transplant patients
Key inclusion criteria (2 listed)
- De novo transplant
- Aged 18-75
Key exclusion criteria (2 listed)
- Serious medical condition which, in the opinion of the Principal Investigator, might interfere with the subject's ability to successfully complete the protocol.
- Any medical condition which, in the opinion of the Principal Investigator, might compromise the safety of the subject in participating in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BK Virus Viremia titer, >400 copies by Polymerase Chain Reaction (PCR)
Time frame: One year
BKVV (BK Visus Viremia) titer is measured by PCR at 1, 3,6,9 and 12 month time points.
1 secondary outcome
Incidence of Acute Rejection of Transplanted Kidney
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
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.
Herwig-Ulf Meier-Kriesche, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disease Due to BK Polyomavirus and Transplantation Infection, run by University of Florida at 1 site 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BK Virus Viremia titer, >400 copies by Polymerase Chain Reaction (PCR) (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2011.