ViruriaPhase 2NCT01620268
An Open-Label, Study to Treat Patients With Renal Allograft and Polyoma BK Viruria
A Phase 2 study testing Leflunomide and orotic acid in people with Viruria and Viremia, run by Changzheng-Cinkate at 9 sites in United States.
Trial summary
This study will evaluate the clinical efficacy and safety of a combination of leflunomide and orotic acid in kidney transplant patients with high levels of Polyoma BK viruria for the purpose of preventing Polyoma BK viremia and Nephropathy that could lead to kidney transplant loss from viral damage, acute rejection or… Read more about this study
- Who is it for?
- Ages Up to 75 years
- What is being tested?
- Leflunomide and orotic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 9 sitesUnited States
- Study dates
- Jul 2012to Jun 2018
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients, 75 years of age or less, with the diagnosis of renal allograft Polyoma BK viruria of 10 million or more copies/mL in their urine confirmed by PCR at the central laboratory.
- No viremia (viremia is defined as greater than 1,000 copies/ml plasma on two consecutive tests two weeks or more apart as measured at the designated central laboratory),
- Serum creatinine <2.0 mg/dL
- Hct > 30%
- WBC > 3,500 x 103/L
- Platelet count > 150,000 x 103/L
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- Normal values for ALT, AST and bilirubin; Alk Phos < 2 X upper limits of normal
- No symptomatic cardiac, pulmonary, GI, hepatic or neurologic disease
- No other active infections
- Receiving CyA or Tacrolimus, Mycophenolate/Azathioprine + prednisone.
- Is not pregnant as verified by a pregnancy test
Who cannot join
- Is not able to comply with study procedures and dosing.
- Has psychiatric instability.
- Has an active systemic infection including Hepatitis B or C, HIV, or on anti-viral therapy within seven days of entering the study. Note however, that the subjects may be taking ganciclovir, valaciclovir, acyclovir and valganciclovir and therefore these are not exclusionary antiviral medications.
- Has BK viremia (viremia is defined as greater than 1,000 copies/ml plasma on two consecutive tests two weeks or more apart as measured at the designated central laboratory), or has had a single episode of BK viremia. (viremia is defined as greater than 1,000 copies/ml plasma on two consecutive tests two weeks or more apart as measured at the designated central laboratory or the local laboratory),
- Has a cancer diagnosis within past five years with potential for recurrence.
- Has received experimental drug within past 3 months.
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- Is receiving immune suppressive drug other than those listed above calcineurin inhibitor, mycophenolate/azathioprine and +/- corticosteroid)
- Is a woman of child bearing potential or is a male with female partner of child bearing potential who is unwilling to use reliable contraception.
- Has any neurologic abnormalities including peripheral neuropathy.
- Is receiving concomitant therapy with drug known to have hepatotoxic risk.
- Has known or suspected liver disease or current alcohol abuse.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Alabama, Birmingham
Birmingham, Alabama, 35294
Beth Israel Deaconess Hospital
Boston, Massachusetts, 02215
Rush Univeristy
Chicago, Illinois, 60612
University of Illinois, Chicago
Chicago, Illinois, 60612
The University of Chicago Transplant Center
Chicago, Illinois, 60637
IU Health
Indianapolis, Indiana, 46202
University of Lousiville
Louisville, Kentucky, 40202
Methodist University Hospital
Memphis, Tennessee, 38104
Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: An Open-Label, Phase 2 Study to Treat Patients With Renal Allograft and Polyoma BK Viruria to Prevent Polyoma BK Viremia, Polyoma BK Nephropathy and Renal Allograft Rejection
This study will evaluate the clinical efficacy and safety of a combination of leflunomide and orotic acid in kidney transplant patients with high levels of Polyoma BK viruria for the purpose of preventing Polyoma BK viremia and Nephropathy that could lead to kidney transplant loss from viral damage, acute rejection or both.
Read the detailed description
This is a multicenter, randomized trial that will evaluate the effect of a combination of leflunomide and orotic acid for the treatment of Polyoma BK viruria. In this multicenter trial, renal allograft patients with the diagnosis of Polyoma BK viruria as determined by a viral level in the urine of 25 million or more copies/mL, and no detectable viremia, will complete a screening visit (V1) to determine eligibility for the study based on inclusion/exclusion criteria. Patients that meet the entrance criteria for this study will be randomly assigned to one of two treatment groups at Visit (2) and enter a 4 month dosing period.
- Being tested
- Leflunomide and orotic acid
- Keywords
- leflunomide, orotic acid, Polyoma BK Viruria, Polyoma BK Viremia, Polyoma BK Nephropathy, Renal Allograft Rejection
- Medical subject headings
- Viremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leflunomide and orotic acidDrug
Daily dose of leflunomide adjusted to target steady state blood levels of 50 ug/mL to 100 ug/mL of the active metabolite plus 600 mg orotic acid
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients receive standard of care. |
| Treatment Group | Experimental | Dose adjusted leflunomide plus 600 mg orotic acid. Receives: Drug: Leflunomide and orotic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of viruria
Viral load of Polyoma BK virus in urine reduced from greater than or equal to 10 million copies/mL to less than 500,000 copies/mL or a 2 log reduction in copies/mL.
Measured: 12 weeks
Secondary outcomes (3)
Absence of viremia
No more that 1000 copies of Polyoma BK Virus in the blood on two consecutive tests 2 weeks or more apart
Measured: 12 weeks
Absence of Polyoma BK Nephropathy
Absence of Polyoma BK Nephropathy
Measured: 12 weeks
No rejection of the renal allograft
No rejection of the renal allograft
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2018
- Study completionJun 2018
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViruriaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changzheng-Cinkate
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James W Williams, MD, Principal investigator, Cinkate Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620268
- Sponsor's protocol ID
- CK2012-001
- Status last verified
- Dec 2018
- First submitted
- 13 Jun 2012
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 2 Study to Treat Patients With Renal Allograft and Polyoma BK Viruria to Prevent Polyoma BK Viremia, Polyoma BK Nephropathy and Renal Allograft Rejection
- ClinicalTrials.gov ID
- NCT01620268
- Acronym / sponsor ID
- CK2012-001
- Keywords
- leflunomide, orotic acid, Polyoma BK Viruria, Polyoma BK Viremia, Polyoma BK Nephropathy, Renal Allograft Rejection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Changzheng-CinkateIndustry (pharma, biotech, devices)
- Study start
- Jul 2012 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 15 Jun 2012 (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.
This study will evaluate the clinical efficacy and safety of a combination of leflunomide and orotic acid in kidney transplant patients with high levels of Polyoma BK viruria for the purpose of preventing Polyoma BK viremia and Nephropathy that could lead to kidney transplant loss from viral damage, acute rejection or both.
Detailed description
This is a multicenter, randomized trial that will evaluate the effect of a combination of leflunomide and orotic acid for the treatment of Polyoma BK viruria. In this multicenter trial, renal allograft patients with the diagnosis of Polyoma BK viruria as determined by a viral level in the urine of 25 million or more copies/mL, and no detectable viremia, will complete a screening visit (V1) to determine eligibility for the study based on inclusion/exclusion criteria. Patients that meet the entrance criteria for this study will be randomly assigned to one of two treatment groups at Visit (2) and enter a 4 month dosing period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients receive standard of care. |
| Treatment Group | Experimental | Drug: Leflunomide and orotic acidDose adjusted leflunomide plus 600 mg orotic acid. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patients, 75 years of age or less, with the diagnosis of renal allograft Polyoma BK viruria of 10 million or more copies/mL in their urine confirmed by PCR at the central laboratory.
- No viremia (viremia is defined as greater than 1,000 copies/ml plasma on two consecutive tests two weeks or more apart as measured at the designated central laboratory),
- Serum creatinine <2.0 mg/dL
- Hct > 30%
- WBC > 3,500 x 103/L
Key exclusion criteria (11 listed)
- Is not able to comply with study procedures and dosing.
- Has psychiatric instability.
- Has an active systemic infection including Hepatitis B or C, HIV, or on anti-viral therapy within seven days of entering the study. Note however, that the subjects may be taking ganciclovir, valaciclovir, acyclovir and valganciclovir and therefore these are not exclusionary antiviral medications.
- Has BK viremia (viremia is defined as greater than 1,000 copies/ml plasma on two consecutive tests two weeks or more apart as measured at the designated central laboratory), or has had a single episode of BK viremia. (viremia is defined as greater than 1,000 copies/ml plasma on two consecutive tests two weeks or more apart as measured at the designated central laboratory or the local laboratory),
- Has a cancer diagnosis within past five years with potential for recurrence.
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 |
|---|---|---|
| Leflunomide and orotic acidDaily dose of leflunomide adjusted to target steady state blood levels of 50 ug/mL to 100 ug/mL of the active metabolite plus 600 mg orotic acid | Drug | Treatment Group |
Primary outcome
Clearance of viruria
Time frame: 12 weeks
Viral load of Polyoma BK virus in urine reduced from greater than or equal to 10 million copies/mL to less than 500,000 copies/mL or a 2 log reduction in copies/mL.
3 secondary outcomes
Absence of viremia
Time frame: 12 weeks
Absence of Polyoma BK Nephropathy
Time frame: 12 weeks
No rejection of the renal allograft
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
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.
James W Williams, MD principal investigator
Cinkate Corp
9 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 Leflunomide and orotic acid in people with Viruria and Viremia, run by Changzheng-Cinkate at 9 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 11 inclusion and 11 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 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 (reason given: Lack of recruitment). 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?
Clearance of viruria (time frame: 12 weeks). 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 5 Dec 2018.