Cardiovascular DiseasePhase 4COBACAMNCT02058875
Cardiovascular Risk Following Conversion to Full Dose Myfortic® and Neoral® Two-hour Post Level Monitoring
A Phase 4 study testing Myfortic®, Neoral® and Cellcept® in people with Cardiovascular Disease and Cardiovascular Outcomes, run by University of Saskatchewan at 2 sites in Canada.
Trial summary
The overall goal of this study is to improve cardiovascular outcomes in transplant recipients. The current standard immunosuppressive regimen in kidney transplant recipients depends on a higher exposure to the Calcineurin Inhibitor (CNI), and often a less than optimal dosage the of mycophenolic acid (MPA) derivative. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Cardiovascular Disease, Cardiovascular Outcomes, Kidney Transplant Recipients
- What is being tested?
- Myfortic®, Neoral® and Cellcept®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2014to Oct 2015
- Phase
- Phase 4
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney transplant patients followed as outpatients who are currently stabilized on immunosuppressive therapy with an MPA derivative, a CNI and prednisone where stability is defined as change in serum creatinine of less than 10% or over the last three months.
- Age 18-74 years old.
- At least six months after transplantation.
- Lack of transplant rejection within the last 12 weeks.
- Serum creatinine less than 300 umol/L at enrolment.
- Negative urine pregnancy test for female patients of childbearing potential.
- Consent to the study.
- Not included in another interventional clinical trial within the last 90 days.
Who cannot join
- Patients with other types of solid organ transplants.
- Patients with any form of substance abuse or major psychiatric disorder.
- Patients with acute or chronic diarrhea, known bowel disease or known gastroparesis.
- Patients receiving anti-lymphocyte treatment for rejection within the last six months.
- Patients not receiving a mycophenolic acid derivative.
- Patients who do not tolerate the maximum Myfortic® total daily dose of 1440 mg OD.
Show all 13Show fewer
- Patients with significant liver disease defined as having an elevated bilirubin by at least two times the upper value of the normal range.
- Patients who have any unstable medical condition that could interfere with the study.
- Patients with chronic viral infection with HIV, Hepatitis B \& C.
- Presence of any acute illness requiring admission to the hospital for the last 4 weeks.
- Pregnancy.
- Significant cardiovascular event such as MI, stroke or TIA within the last 12 weeks or uncontrolled hypertension.
- Immunosuppressant changes within the last month.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Kidney Health Center
Regina, Saskatchewan, S4R 3C2
St. Paul's Hospital
Saskatoon, Saskatchewan, S7M 0Z9
About this study
Official title: Comparisons Of Inflammatory Biomarkers And Cardiovascular Risk Scores Before And After Conversion To Full Dose Myfortic® Using Two Hour Neoral® Monitoring.
The overall goal of this study is to improve cardiovascular outcomes in transplant recipients. The current standard immunosuppressive regimen in kidney transplant recipients depends on a higher exposure to the Calcineurin Inhibitor (CNI), and often a less than optimal dosage the of mycophenolic acid (MPA) derivative. The premise of this study is to investigate the effects of reversing this paradigm. More specifically, the effect of using maximum MPA dosages (in the form of enteric-coated mycophenolate sodium [EC-MPS] or Myfortic®) along with judicious CNI exposure (cyclosporine/Neoral®) will be investigated.
Read the detailed description
Research Question:
Will treating kidney transplant recipients with maximum MPA dosages (in the form of EC-MPS or Myfortic®) along with judicious CNI exposure (cyclosporine/Neoral®) lead to improved cardiovascular outcomes, as measured by the Framingham Risk Score, 7-year major adverse cardiac events (MACE) score and cardiovascular risk inflammatory biomarker profile?
Primary Objectives:
- To improve the Framingham Risk Score and 7-year MACE score for renal transplant recipients, which estimate risk for cardiovascular disease.
- To improve the cardiovascular risk inflammatory biomarker profile.
Hypothesis:
The more consistent drug exposure and lower Cmax noted with monitoring cyclosporine using the 2h levels (C2) combined with full dose Myfortic® will decrease Framingham Risk Score, MACE score, as well as markers of inflammation in kidney transplant recipients because:
- CNI minimization protocols are widely accepted as a strategy to ameliorate allograft and vascular injury.
- Chronic allograft injury and vascular disease are known inflammatory conditions.
- The MPA derivatives possess significant anti-inflammatory properties.
- Conditions
- Cardiovascular Disease, Cardiovascular Outcomes, Kidney Transplant Recipients, Kidney Transplantation
- Being tested
- Myfortic®, Neoral®, Cellcept®, Prednisone
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myfortic®Drug
Also called mycophenolate sodium, MPA derivative
Neoral®Drug
Also called cyclosporine
Cellcept®Drug
PrednisoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Maximization of mycophenolicacid (MPA) derivative (to a total daily dosage of 1440mg of Myfortic®) and reduction of cyclosporine dosage (as defined by C2 monitoring) in 50 stable renal transplant patients previously on immunosuppressive therapy with cyclosporine, an MPA derivative and prednisone. Receives: Drug: Myfortic®; Drug: Neoral® |
| Control Group | Active comparator | 25 patients continued on an mycophenolicacid (MPA) derivative, cyclosporine and prednisone. Receives: Drug: Myfortic®; Drug: Cellcept®; Drug: Prednisone |
| Observation Group | No intervention | 25 patients continued on an mycophenolic acid (MPA) derivative, tacrolimus, and prednisone will be followed during the same recruitment period as an additional comparison, as this is the other Calcineurin Inhibitor (CNI), which is used in kidney transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Framingham score for renal transplant recipients.
Cardiovascular risk factors using the Framingham 2009 risk score for renal transplant recipients and at end of the one year.
Measured: 1 year
Surrogate markers for potential biological differences between the groups.
Cardiovascular (CV) Biomarkers compared between each group. CV Biomarkers of interest in this study include:
- Chemokines (including ccl 1, 2, 15 and Clx 9 and 10)
- Thrombopoitin
- Cytokines IL 1, 2, 4, 6, 10, TGF, INF.
These mediators are known to play a pivital role in atherosclerosis and progressive kidney failure.
Measured: 1 year
Safety Measures
Safety will be measured by estimated Glomerular filtration rate (GFR).
Measured: 1 year
Change in 7-year MACE score for renal transplant recipients.
Cardiovascular risk factors using the 7-year MACE calculator for renal transplant recipients and at end of the one year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: The study funder retracted their grant funding offer before contract signed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AShoker, University of Saskatchewan
- Investigators
- Ahmed Shoker, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058875
- Sponsor's protocol ID
- CERL080ACA15T
- Acronym
- COBACAM
- Status last verified
- Jan 2017
- First submitted
- 15 Jan 2014
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ojo AO. Cardiovascular complications after renal transplantation and their prevention. Transplantation. 2006 Sep 15;82(5):603-11. doi: 10.1097/01.tp.0000235527.81917.fe.
PubMed 16969281Barama A, Sepandj F, Gough J, McKenna R. Correlation between Neoral 2 hours post-dose levels and histologic findings on surveillance biopsies. Transplant Proc. 2004 Mar;36(2 Suppl):465S-467S. doi: 10.1016/j.transproceed.2003.12.039.
PubMed 15041389Behrend M, Braun F. Enteric-coated mycophenolate sodium: tolerability profile compared with mycophenolate mofetil. Drugs. 2005;65(8):1037-50. doi: 10.2165/00003495-200565080-00001.
PubMed 15907141Bolin P Jr, Gohh R, Kandaswamy R, Shihab FS, Wiland A, Akhlaghi F, Melancon K. Mycophenolic acid in kidney transplant patients with diabetes mellitus: does the formulation matter? Transplant Rev (Orlando). 2011 Jul;25(3):117-23. doi: 10.1016/j.trre.2010.12.003. Epub 2011 Apr 29.
PubMed 21530217Carstens J. Three-years experience with Neoral C2 monitoring adjusted to a target range of 500-600 ng/ml in long-term renal transplant recipients receiving dual immunosuppressive therapy. Scand J Urol Nephrol. 2008;42(3):286-92. doi: 10.1080/00365590701748039.
PubMed 18432535Cibrik D, Meier-Kriesche HU, Bresnahan B, Wu YM, Klintmalm G, Kew CE, Kuo PC, Whelchel J, Cohen D, Baliga P, Akalin E, Benedetti E, Wright F, Lieberman B, Ulbricht B, Jensik S; Myfortic-US01 Renal Transplant Study Group. Renal function with cyclosporine C2 monitoring, enteric-coated mycophenolate sodium and basiliximab: a 12-month randomized trial in renal transplant recipients. Clin Transplant. 2007 Mar-Apr;21(2):192-201. doi: 10.1111/j.1399-0012.2006.00622.x.
PubMed 17425744Citterio F. Evolution of the therapeutic drug monitoring of cyclosporine. Transplant Proc. 2004 Mar;36(2 Suppl):420S-425S. doi: 10.1016/j.transproceed.2004.01.054.
PubMed 15041378Cuero C, Delgado E, de Gonzalez M, Medina C, Vernaza A, Moscoso J. [C0 vs C2 levels and their implications in kidney transplantation]. Rev Med Panama. 2002;27:30-3. Spanish.
PubMed 16737196Dominguez J, Fuenzalida D, Norambuena R, Pais E, Cortes Monroy G, Llanos R. C2 monitoring of cyclosporine in stable renal transplant patients results in lower costs and improved renal function. Transplant Proc. 2005 Apr;37(3):1583-5. doi: 10.1016/j.transproceed.2004.09.016.
PubMed 15866680Gozdowska J, Urbanowicz AL, Galazka Z, Chmura A, Durlik M. Tolerance of enteric-coated mycophenolate sodium in combination with calcineurin inhibitor in kidney transplant recipients: Polish experience. Transplant Proc. 2011 Oct;43(8):2946-9. doi: 10.1016/j.transproceed.2011.08.056.
PubMed 21996197Hernandez D, Moreso F. Has patient survival following renal transplantation improved in the era of modern immunosuppression? Nefrologia. 2013;33(2):171-80. doi: 10.3265/Nefrologia.pre2012.Nov.11743. English, Spanish.
PubMed 23511753Hoorn EJ, Walsh SB, McCormick JA, Furstenberg A, Yang CL, Roeschel T, Paliege A, Howie AJ, Conley J, Bachmann S, Unwin RJ, Ellison DH. The calcineurin inhibitor tacrolimus activates the renal sodium chloride cotransporter to cause hypertension. Nat Med. 2011 Oct 2;17(10):1304-9. doi: 10.1038/nm.2497.
PubMed 21963515Jardine AG, Fellstrom B, Logan JO, Cole E, Nyberg G, Gronhagen-Riska C, Madsen S, Neumayer HH, Maes B, Ambuhl P, Olsson AG, Pedersen T, Holdaas H. Cardiovascular risk and renal transplantation: post hoc analyses of the Assessment of Lescol in Renal Transplantation (ALERT) Study. Am J Kidney Dis. 2005 Sep;46(3):529-36. doi: 10.1053/j.ajkd.2005.05.014.
PubMed 16129216Kahan BD, Podbielski J, Childs B. The impact of conversion from mycophenolate mofetil to mycophenolate sodium among renal transplant recipients on a sirolimus-based regimen. Transplant Proc. 2008 Jun;40(5):1429-34. doi: 10.1016/j.transproceed.2008.04.009.
PubMed 18589123Kamar N, Rostaing L, Cassuto E, Villemain F, Moal MC, Ladriere M, Barrou B, Ducloux D, Chaouche K, Quere S, Di Giambattista F, Be F. A multicenter, randomized trial of increased mycophenolic acid dose using enteric-coated mycophenolate sodium with reduced tacrolimus exposure in maintenance kidney transplant recipients. Clin Nephrol. 2012 Feb;77(2):126-36. doi: 10.5414/CN107227.
PubMed 22257543
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons Of Inflammatory Biomarkers And Cardiovascular Risk Scores Before And After Conversion To Full Dose Myfortic® Using Two Hour Neoral® Monitoring.
- ClinicalTrials.gov ID
- NCT02058875
- Acronym / sponsor ID
- COBACAM / CERL080ACA15T
- Conditions
- Cardiovascular Disease, Cardiovascular Outcomes, Kidney Transplant Recipients, Kidney Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study funder retracted their grant funding offer before contract signed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 Feb 2014 (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 overall goal of this study is to improve cardiovascular outcomes in transplant recipients. The current standard immunosuppressive regimen in kidney transplant recipients depends on a higher exposure to the Calcineurin Inhibitor (CNI), and often a less than optimal dosage the of mycophenolic acid (MPA) derivative. The premise of this study is to investigate the effects of reversing this paradigm. More specifically, the effect of using maximum MPA dosages (in the form of enteric-coated mycophenolate sodium [EC-MPS] or Myfortic®) along with judicious CNI exposure (cyclosporine/Neoral®) will be investigated.
Detailed description
Research Question:
Will treating kidney transplant recipients with maximum MPA dosages (in the form of EC-MPS or Myfortic®) along with judicious CNI exposure (cyclosporine/Neoral®) lead to improved cardiovascular outcomes, as measured by the Framingham Risk Score, 7-year major adverse cardiac events (MACE) score and cardiovascular risk inflammatory biomarker profile?
Primary Objectives:
- To improve the Framingham Risk Score and 7-year MACE score for renal transplant recipients, which estimate risk for cardiovascular disease.
- To improve the cardiovascular risk inflammatory biomarker profile.
Hypothesis:
The more consistent drug exposure and lower Cmax noted with monitoring cyclosporine using the 2h levels (C2) combined with full dose Myfortic® will decrease Framingham Risk Score, MACE score, as well as markers of inflammation in kidney transplant recipients because:
- CNI minimization protocols are widely accepted as a strategy to ameliorate allograft and vascular injury.
- Chronic allograft injury and vascular disease are known inflammatory conditions.
- The MPA derivatives possess significant anti-inflammatory properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Myfortic®, Drug: Neoral®Maximization of mycophenolicacid (MPA) derivative (to a total daily dosage of 1440mg of Myfortic®) and reduction of cyclosporine dosage (as defined by C2 monitoring) in 50 stable renal transplant patients previously on immunosuppressive therapy with cyclosporine, an MPA derivative and prednisone. |
| Control Group | Active comparator | Drug: Myfortic®, Drug: Cellcept®, Drug: Prednisone25 patients continued on an mycophenolicacid (MPA) derivative, cyclosporine and prednisone. |
| Observation Group | No intervention | –25 patients continued on an mycophenolic acid (MPA) derivative, tacrolimus, and prednisone will be followed during the same recruitment period as an additional comparison, as this is the other Calcineurin Inhibitor (CNI), which is used in kidney transplantation. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Kidney transplant patients followed as outpatients who are currently stabilized on immunosuppressive therapy with an MPA derivative, a CNI and prednisone where stability is defined as change in serum creatinine of less than 10% or over the last three months.
- Age 18-74 years old.
- At least six months after transplantation.
- Lack of transplant rejection within the last 12 weeks.
- Serum creatinine less than 300 umol/L at enrolment.
Key exclusion criteria (13 listed)
- Patients with other types of solid organ transplants.
- Patients with any form of substance abuse or major psychiatric disorder.
- Patients with acute or chronic diarrhea, known bowel disease or known gastroparesis.
- Patients receiving anti-lymphocyte treatment for rejection within the last six months.
- Patients not receiving a mycophenolic acid derivative.
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 |
|---|---|---|
| Myfortic®Also: mycophenolate sodium, MPA derivative | Drug | Control Group, Treatment Group |
| Neoral®Also: cyclosporine | Drug | Treatment Group |
| Cellcept® | Drug | Control Group |
| Prednisone | Drug | Control Group |
Primary outcome
Change in Framingham score for renal transplant recipients.
Time frame: 1 year
Cardiovascular risk factors using the Framingham 2009 risk score for renal transplant recipients and at end of the one year.
Surrogate markers for potential biological differences between the groups.
Time frame: 1 year
Cardiovascular (CV) Biomarkers compared between each group. CV Biomarkers of interest in this study include: 1. Chemokines (including ccl 1, 2, 15 and Clx 9 and 10) 2. Thrombopoitin 3. Cytokines IL 1, 2, 4, 6, 10, TGF, INF. These mediators are known to play a pivital role in atherosclerosis and progressive kidney failure.
Safety Measures
Time frame: 1 year
Safety will be measured by estimated Glomerular filtration rate (GFR).
Change in 7-year MACE score for renal transplant recipients.
Time frame: 1 year
Cardiovascular risk factors using the 7-year MACE calculator for renal transplant recipients and at end of the one year.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Background: PubMed 16969281Ojo AO. Cardiovascular complications after renal transplantation and their prevention. Transplantation. 2006 Sep 15;82(5):603-11. doi: 10.1097/01.tp.0000235527.81917.fe.
- Background: PubMed 15041389Barama A, Sepandj F, Gough J, McKenna R. Correlation between Neoral 2 hours post-dose levels and histologic findings on surveillance biopsies. Transplant Proc. 2004 Mar;36(2 Suppl):465S-467S. doi: 10.1016/j.transproceed.2003.12.039.
- Background: PubMed 15907141Behrend M, Braun F. Enteric-coated mycophenolate sodium: tolerability profile compared with mycophenolate mofetil. Drugs. 2005;65(8):1037-50. doi: 10.2165/00003495-200565080-00001.
- Background: PubMed 21530217Bolin P Jr, Gohh R, Kandaswamy R, Shihab FS, Wiland A, Akhlaghi F, Melancon K. Mycophenolic acid in kidney transplant patients with diabetes mellitus: does the formulation matter? Transplant Rev (Orlando). 2011 Jul;25(3):117-23. doi: 10.1016/j.trre.2010.12.003. Epub 2011 Apr 29.
- Background: PubMed 18432535Carstens J. Three-years experience with Neoral C2 monitoring adjusted to a target range of 500-600 ng/ml in long-term renal transplant recipients receiving dual immunosuppressive therapy. Scand J Urol Nephrol. 2008;42(3):286-92. doi: 10.1080/00365590701748039.
- Background: PubMed 17425744Cibrik D, Meier-Kriesche HU, Bresnahan B, Wu YM, Klintmalm G, Kew CE, Kuo PC, Whelchel J, Cohen D, Baliga P, Akalin E, Benedetti E, Wright F, Lieberman B, Ulbricht B, Jensik S; Myfortic-US01 Renal Transplant Study Group. Renal function with cyclosporine C2 monitoring, enteric-coated mycophenolate sodium and basiliximab: a 12-month randomized trial in renal transplant recipients. Clin Transplant. 2007 Mar-Apr;21(2):192-201. doi: 10.1111/j.1399-0012.2006.00622.x.
- Background: PubMed 15041378Citterio F. Evolution of the therapeutic drug monitoring of cyclosporine. Transplant Proc. 2004 Mar;36(2 Suppl):420S-425S. doi: 10.1016/j.transproceed.2004.01.054.
- Background: PubMed 16737196Cuero C, Delgado E, de Gonzalez M, Medina C, Vernaza A, Moscoso J. [C0 vs C2 levels and their implications in kidney transplantation]. Rev Med Panama. 2002;27:30-3. Spanish.
- Background: PubMed 15866680Dominguez J, Fuenzalida D, Norambuena R, Pais E, Cortes Monroy G, Llanos R. C2 monitoring of cyclosporine in stable renal transplant patients results in lower costs and improved renal function. Transplant Proc. 2005 Apr;37(3):1583-5. doi: 10.1016/j.transproceed.2004.09.016.
- Background: PubMed 21996197Gozdowska J, Urbanowicz AL, Galazka Z, Chmura A, Durlik M. Tolerance of enteric-coated mycophenolate sodium in combination with calcineurin inhibitor in kidney transplant recipients: Polish experience. Transplant Proc. 2011 Oct;43(8):2946-9. doi: 10.1016/j.transproceed.2011.08.056.
- Background: PubMed 23511753Hernandez D, Moreso F. Has patient survival following renal transplantation improved in the era of modern immunosuppression? Nefrologia. 2013;33(2):171-80. doi: 10.3265/Nefrologia.pre2012.Nov.11743. English, Spanish.
- Background: PubMed 21963515Hoorn EJ, Walsh SB, McCormick JA, Furstenberg A, Yang CL, Roeschel T, Paliege A, Howie AJ, Conley J, Bachmann S, Unwin RJ, Ellison DH. The calcineurin inhibitor tacrolimus activates the renal sodium chloride cotransporter to cause hypertension. Nat Med. 2011 Oct 2;17(10):1304-9. doi: 10.1038/nm.2497.
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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.
Ahmed Shoker, MD principal investigator
University of Saskatchewan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Myfortic®, Neoral® and Cellcept® in people with Cardiovascular Disease and Cardiovascular Outcomes, run by University of Saskatchewan at 2 sites in Canada.
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 8 inclusion and 13 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: withdrawn, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 withdrawn before enrolling participants, so there are no results.
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 in Framingham score for renal transplant recipients. (time frame: 1 year). The study lists 4 primary outcomes in all. 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 NCT02058875, which also lists 44 linked publications.
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 9 Jan 2017.