Chronic Kidney DiseasePhase 2/3FAVORITNCT00064753
Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)
A Phase 2/3 study testing High Dose Multivitamin and Low Dose Multivitamin in people with Chronic Kidney Disease and Cardiovascular Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 30 sites in 3 countries.
Trial summary
The purpose of this randomized clinical trial is to determine if lowering homocysteine levels in renal transplant recipients with a multivitamin will reduce the occurrence of cardiovascular disease outcomes. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Chronic Kidney Disease, Cardiovascular Disease, Death
- What is being tested?
- High Dose Multivitamin and Low Dose Multivitamin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,110 participants
- Where
- 30 sitesin 3 countries
- Study dates
- May 2002to Oct 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 35 - 75 years old
- Had kidney transplant at least 6 months
- Calculated Creatinine Clearance must be 25 mL/min or greater
- Must be willing to stop supplements (B6, B12, folic acid) for 4-6 weeks prior to visit
Who cannot join
- If pregnant or lactating
- If of child bearing potential and not on birth control
- If any of the following will limit life expectancy to less than 2 yrs:
- Cancer
- Congestive heart failure (CHF) (end stage)
- Liver disease (end stage)
Show all 13Show fewer
- Severe pulmonary disease
- Progressive HIV
- Any other chronic wasting illness
- If patient had myocardial infarction (MI), stroke, lower extremity amputation above ankle or percutaneous revascularization procedure (coronary, cerebrovascular, lower extremity) in past 2months
- If patient had coronary artery bypass graft (CABG) or abdominal aortic aneurysm (AAA) in past 5 months
- If patient has conditions that prevent reliable study participation e.g., depression, alcohol or drug abuse, other cardiovascular disease (CVD) studies
- If patient has had multi-organ transplant, except kidney/pancreas
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
United States27 sites
Albany Medical Center
Albany, New York, 12208
University of Michigan Medical Center
Ann Arbor, Michigan, 48109-0364
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, 35233
Brigham and Women's Hospital
Boston, Massachusetts, 02120
State University of New York Downstate Medical Center
Brooklyn, New York, 11203
Northwestern University
Chicago, Illinois, 60611
The Ohio State University Medical Center
Columbus, Ohio, 43210-1228
Duke University Medical Center
Durham, North Carolina, 27710
East Carolina University
Greenville, North Carolina, 27834
Indiana University
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Cedars-Sinai Health System/Center for Kidney Diseases and Transplantation
Los Angeles, California, 90048
University of California at Los Angeles
Los Angeles, California, 90095-7306
University of Wisconsin at Madison
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Hennepin County Medical Center
Minneapolis, Minnesota, 55404
Faireview University Medical Center
Minneapolis, Minnesota, 55455
Drexel University
Philadelphia, Pennsylvania, 19102-1192
Banner Good Samaritan Transplant
Phoenix, Arizona, 85004-1608
Maine Medical Center
Portland, Maine, 04102
Oregon Health Sciences University
Portland, Oregon, 97201-2940
Rhode Island Hospital
Providence, Rhode Island, 02903
Mayo Clinic
Rochester, Minnesota, 55905
University of California at San Francisco
San Francisco, California, 94143-0780
Southern Illinois University
Springfield, Illinois, 62794-9638
Washington University
St Louis, Missouri, 63110
Canada2 sites
London Health Sciences Center
London, Ontario, N6A 5A5
Toronto General Hospital
Toronto, Ontario, M5G 2N2
About this study
The purpose of this randomized clinical trial is to determine if lowering homocysteine levels in renal transplant recipients with a multivitamin will reduce the occurrence of cardiovascular disease outcomes.
Read the detailed description
The hypothesis of the trial is as follows: Treatment with a high dose combination of folic acid, vitamin B6, and vitamin B12 will reduce the rate of pooled arteriosclerotic cardiovascular disease outcomes (i.e., pooled occurrence of non-fatal and fatal arteriosclerotic outcomes, including coronary heart, cerebrovascular, and peripheral vascular disease events) relative to treatment with an identical multivitamin containing no folic acid, and Estimated Average Requirement amounts of vitamin B6, vitamin B12, among chronic, stable renal transplant recipients
- Conditions
- Chronic Kidney Disease, Cardiovascular Disease, Death
- Being tested
- High Dose Multivitamin, Low Dose Multivitamin
- Keywords
- homocysteine, multi-vitamin, cardiovascular disease, renal transplant recipients
- Medical subject headings
- Renal Insufficiency, Chronic, Cardiovascular Diseases, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose MultivitaminDrug
Also called multivitamin
Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
Low Dose MultivitaminDevice
Also called multivitamin
Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
| Study group | Role | What they receive |
|---|---|---|
| High Dose Multivitamin | Experimental | Multivitamin with increased folic acid, vitamin B6 and vitamin B12 Receives: Drug: High Dose Multivitamin |
| Low Dose Multivitamin | Active comparator | Multivitamin devoid of folic acid and with estimated average requirement amounts of vitamin B6 and vitamin B12 Receives: Device: Low Dose Multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events
Measured: Up to 6 years (mean 4 years)
Secondary outcomes (11)
Renal Graft Failure
Measured: Up to 6 years (mean 4 years)
Mortality (All-cause)
censored at 3 months after return to dialysis
Measured: Up to 6 years (mean 4 years)
Fatal/Non-fatal Myocardial Infarction (MI)
censored at 3 months after return to dialysis
Measured: Up to 6 years (mean 4 years)
Fatal/Non-fatal Stroke
censored at 3 months after return to dialysis
Measured: Up to 6 years (mean 4 years)
Resuscitated Sudden Death (RSD)
censored at 3 months after return to dialysis
Measured: Up to 6 years (mean 4 years)
CVD Death
censored at 3 months after return to dialysis
Measured: Up to 6 years (mean 4 years)
Coronary Artery Revascularization
censored at 3 months after return to dialysis
Measured: Up to 6 years (mean 4 years)
Lower Extremity Peripheral Arterial Disease (PAD)
censored at 3 months after return to dialysis
Measured: Up to 6 years (mean 4 years)
Carotid Endarterectomy or Angioplasty
censored at 3 months after return to dialysis
Measured: Up to 6 years (mean 4 years)
Abdominal Aortic Aneurysm Repair
censored at 3 months after return to dialysis
Measured: Up to 6 years (mean 4 years)
Renal Artery Revascularization
censored at 3 months after return to dialysis
Measured: Up to 6 years (mean 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2003 (estimated)
- Study startMay 2002
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,110 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Office of Dietary Supplements (ODS)
- Responsible party
- Sponsor
- Investigators
- Andrew Levey, M.D., Study director, Tufts Medical CenterMyra A Carpenter, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064753
- Sponsor's protocol ID
- FAVORIT dk61700 IND
- Other IDs
- U01DK061700
- Acronym
- FAVORIT
- Status last verified
- Oct 2015
- First submitted
- 11 Jul 2003
- Last updated
- 18 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data and samples are available at the NIDDK Central repository
Publications
Weiner DE, Carpenter MA, Levey AS, Ivanova A, Cole EH, Hunsicker L, Kasiske BL, Kim SJ, Kusek JW, Bostom AG. Kidney function and risk of cardiovascular disease and mortality in kidney transplant recipients: the FAVORIT trial. Am J Transplant. 2012 Sep;12(9):2437-45. doi: 10.1111/j.1600-6143.2012.04101.x. Epub 2012 May 17.
PubMed 22594581Troen AM, Scott TM, D'Anci KE, Moorthy D, Dobson B, Rogers G, Weiner DE, Levey AS, Dallal GE, Jacques PF, Selhub J, Rosenberg IH; FACT Study Investigators. Cognitive dysfunction and depression in adult kidney transplant recipients: baseline findings from the FAVORIT Ancillary Cognitive Trial (FACT). J Ren Nutr. 2012 Mar;22(2):268-276.e3. doi: 10.1053/j.jrn.2011.07.009. Epub 2011 Dec 6.
PubMed 22153382Carpenter MA, Weir MR, Adey DB, House AA, Bostom AG, Kusek JW. Inadequacy of cardiovascular risk factor management in chronic kidney transplantation - evidence from the FAVORIT study. Clin Transplant. 2012 Jul-Aug;26(4):E438-46. doi: 10.1111/j.1399-0012.2012.01676.x. Epub 2012 Jul 9.
PubMed 22775763Bostom AG, Carpenter MA, Kusek JW, Hunsicker LG, Pfeffer MA, Levey AS, Jacques PF, McKenney J; FAVORIT Investigators. Rationale and design of the Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT) trial. Am Heart J. 2006 Sep;152(3):448.e1-7. doi: 10.1016/j.ahj.2006.03.004.
PubMed 16923411Weir MR, Gravens-Muller L, Costa N, Ivanova A, Manitpisitkul W, Bostom AG, Diamantidis CJ; FAVORIT Study Investigators. Safety events in kidney transplant recipients: results from the folic Acid for vascular outcome reduction in transplant trial. Transplantation. 2015 May;99(5):1003-8. doi: 10.1097/TP.0000000000000454.
PubMed 25393158Carpenter MA, John A, Weir MR, Smith SR, Hunsicker L, Kasiske BL, Kusek JW, Bostom A, Ivanova A, Levey AS, Solomon S, Pesavento T, Weiner DE. BP, cardiovascular disease, and death in the Folic Acid for Vascular Outcome Reduction in Transplantation trial. J Am Soc Nephrol. 2014 Jul;25(7):1554-62. doi: 10.1681/ASN.2013040435. Epub 2014 Mar 13.
PubMed 24627349Bostom AG, Carpenter MA, Hunsicker L, Jacques PF, Kusek JW, Levey AS, McKenney JL, Mercier RY, Pfeffer MA, Selhub J; FAVORIT Study Investigators. Baseline characteristics of participants in the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial. Am J Kidney Dis. 2009 Jan;53(1):121-8. doi: 10.1053/j.ajkd.2008.08.010. Epub 2008 Nov 20.
PubMed 19022547Bostom AG, Carpenter MA, Kusek JW, Levey AS, Hunsicker L, Pfeffer MA, Selhub J, Jacques PF, Cole E, Gravens-Mueller L, House AA, Kew C, McKenney JL, Pacheco-Silva A, Pesavento T, Pirsch J, Smith S, Solomon S, Weir M. Homocysteine-lowering and cardiovascular disease outcomes in kidney transplant recipients: primary results from the Folic Acid for Vascular Outcome Reduction in Transplantation trial. Circulation. 2011 Apr 26;123(16):1763-70. doi: 10.1161/CIRCULATIONAHA.110.000588. Epub 2011 Apr 11.
PubMed 21482964Kang AW, Garber CE, Eaton CB, Risica PM, Bostom AG. Physical Activity and Cardiovascular Risk among Kidney Transplant Patients. Med Sci Sports Exerc. 2019 Jun;51(6):1154-1161. doi: 10.1249/MSS.0000000000001886.
PubMed 30629045Weinrauch LA, Claggett B, Liu J, Finn PV, Weir MR, Weiner DE, D'Elia JA. Smoking and outcomes in kidney transplant recipients: a post hoc survival analysis of the FAVORIT trial. Int J Nephrol Renovasc Dis. 2018 Apr 27;11:155-164. doi: 10.2147/IJNRD.S161001. eCollection 2018.
PubMed 29760559Weinrauch LA, D'Elia JA, Weir MR, Bunnapradist S, Finn PV, Liu J, Claggett B, Monaco AP. Infection and Malignancy Outweigh Cardiovascular Mortality in Kidney Transplant Recipients: Post Hoc Analysis of the FAVORIT Trial. Am J Med. 2018 Feb;131(2):165-172. doi: 10.1016/j.amjmed.2017.08.038. Epub 2017 Sep 21.
PubMed 28943384
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)
- ClinicalTrials.gov ID
- NCT00064753
- Acronym / sponsor ID
- FAVORIT / FAVORIT dk61700 IND
- Conditions
- Chronic Kidney Disease, Cardiovascular Disease, Death
- Keywords
- homocysteine, multi-vitamin, cardiovascular disease, renal transplant recipients
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,110 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Office of Dietary Supplements (ODS)
- Study start
- May 2002
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Jul 2003 (estimated)
- Results
- Posted 26 Nov 2015
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 randomized clinical trial is to determine if lowering homocysteine levels in renal transplant recipients with a multivitamin will reduce the occurrence of cardiovascular disease outcomes.
Detailed description
The hypothesis of the trial is as follows: Treatment with a high dose combination of folic acid, vitamin B6, and vitamin B12 will reduce the rate of pooled arteriosclerotic cardiovascular disease outcomes (i.e., pooled occurrence of non-fatal and fatal arteriosclerotic outcomes, including coronary heart, cerebrovascular, and peripheral vascular disease events) relative to treatment with an identical multivitamin containing no folic acid, and Estimated Average Requirement amounts of vitamin B6, vitamin B12, among chronic, stable renal transplant recipients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Dose Multivitamin | Experimental | Drug: High Dose MultivitaminMultivitamin with increased folic acid, vitamin B6 and vitamin B12 |
| Low Dose Multivitamin | Active comparator | Device: Low Dose MultivitaminMultivitamin devoid of folic acid and with estimated average requirement amounts of vitamin B6 and vitamin B12 |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 35 - 75 years old
- Had kidney transplant at least 6 months
- Calculated Creatinine Clearance must be 25 mL/min or greater
- Must be willing to stop supplements (B6, B12, folic acid) for 4-6 weeks prior to visit
Key exclusion criteria (13 listed)
- If pregnant or lactating
- If of child bearing potential and not on birth control
- If any of the following will limit life expectancy to less than 2 yrs:
- If patient had myocardial infarction (MI), stroke, lower extremity amputation above ankle or percutaneous revascularization procedure (coronary, cerebrovascular, lower extremity) in past 2months
- If patient had coronary artery bypass graft (CABG) or abdominal aortic aneurysm (AAA) in past 5 months
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 |
|---|---|---|
| High Dose MultivitaminAlso: multivitaminVitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg | Drug | High Dose Multivitamin |
| Low Dose MultivitaminAlso: multivitaminVitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg | Device | Low Dose Multivitamin |
Primary outcome
Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events
Time frame: Up to 6 years (mean 4 years)
11 secondary outcomes
Renal Graft Failure
Time frame: Up to 6 years (mean 4 years)
Mortality (All-cause)
Time frame: Up to 6 years (mean 4 years)
Fatal/Non-fatal Myocardial Infarction (MI)
Time frame: Up to 6 years (mean 4 years)
Fatal/Non-fatal Stroke
Time frame: Up to 6 years (mean 4 years)
Resuscitated Sudden Death (RSD)
Time frame: Up to 6 years (mean 4 years)
CVD Death
Time frame: Up to 6 years (mean 4 years)
Coronary Artery Revascularization
Time frame: Up to 6 years (mean 4 years)
Lower Extremity Peripheral Arterial Disease (PAD)
Time frame: Up to 6 years (mean 4 years)
Carotid Endarterectomy or Angioplasty
Time frame: Up to 6 years (mean 4 years)
Abdominal Aortic Aneurysm Repair
Time frame: Up to 6 years (mean 4 years)
Renal Artery Revascularization
Time frame: Up to 6 years (mean 4 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22594581Weiner DE, Carpenter MA, Levey AS, Ivanova A, Cole EH, Hunsicker L, Kasiske BL, Kim SJ, Kusek JW, Bostom AG. Kidney function and risk of cardiovascular disease and mortality in kidney transplant recipients: the FAVORIT trial. Am J Transplant. 2012 Sep;12(9):2437-45. doi: 10.1111/j.1600-6143.2012.04101.x. Epub 2012 May 17.
- Background: PubMed 22153382Troen AM, Scott TM, D'Anci KE, Moorthy D, Dobson B, Rogers G, Weiner DE, Levey AS, Dallal GE, Jacques PF, Selhub J, Rosenberg IH; FACT Study Investigators. Cognitive dysfunction and depression in adult kidney transplant recipients: baseline findings from the FAVORIT Ancillary Cognitive Trial (FACT). J Ren Nutr. 2012 Mar;22(2):268-276.e3. doi: 10.1053/j.jrn.2011.07.009. Epub 2011 Dec 6.
- Background: PubMed 22775763Carpenter MA, Weir MR, Adey DB, House AA, Bostom AG, Kusek JW. Inadequacy of cardiovascular risk factor management in chronic kidney transplantation - evidence from the FAVORIT study. Clin Transplant. 2012 Jul-Aug;26(4):E438-46. doi: 10.1111/j.1399-0012.2012.01676.x. Epub 2012 Jul 9.
- Background: PubMed 16923411Bostom AG, Carpenter MA, Kusek JW, Hunsicker LG, Pfeffer MA, Levey AS, Jacques PF, McKenney J; FAVORIT Investigators. Rationale and design of the Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT) trial. Am Heart J. 2006 Sep;152(3):448.e1-7. doi: 10.1016/j.ahj.2006.03.004.
- Background: PubMed 25393158Weir MR, Gravens-Muller L, Costa N, Ivanova A, Manitpisitkul W, Bostom AG, Diamantidis CJ; FAVORIT Study Investigators. Safety events in kidney transplant recipients: results from the folic Acid for vascular outcome reduction in transplant trial. Transplantation. 2015 May;99(5):1003-8. doi: 10.1097/TP.0000000000000454.
- Background: PubMed 24627349Carpenter MA, John A, Weir MR, Smith SR, Hunsicker L, Kasiske BL, Kusek JW, Bostom A, Ivanova A, Levey AS, Solomon S, Pesavento T, Weiner DE. BP, cardiovascular disease, and death in the Folic Acid for Vascular Outcome Reduction in Transplantation trial. J Am Soc Nephrol. 2014 Jul;25(7):1554-62. doi: 10.1681/ASN.2013040435. Epub 2014 Mar 13.
- Results publication: PubMed 19022547Bostom AG, Carpenter MA, Hunsicker L, Jacques PF, Kusek JW, Levey AS, McKenney JL, Mercier RY, Pfeffer MA, Selhub J; FAVORIT Study Investigators. Baseline characteristics of participants in the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial. Am J Kidney Dis. 2009 Jan;53(1):121-8. doi: 10.1053/j.ajkd.2008.08.010. Epub 2008 Nov 20.
- Results publication: PubMed 21482964Bostom AG, Carpenter MA, Kusek JW, Levey AS, Hunsicker L, Pfeffer MA, Selhub J, Jacques PF, Cole E, Gravens-Mueller L, House AA, Kew C, McKenney JL, Pacheco-Silva A, Pesavento T, Pirsch J, Smith S, Solomon S, Weir M. Homocysteine-lowering and cardiovascular disease outcomes in kidney transplant recipients: primary results from the Folic Acid for Vascular Outcome Reduction in Transplantation trial. Circulation. 2011 Apr 26;123(16):1763-70. doi: 10.1161/CIRCULATIONAHA.110.000588. Epub 2011 Apr 11.
- Derived from this study: PubMed 30629045Kang AW, Garber CE, Eaton CB, Risica PM, Bostom AG. Physical Activity and Cardiovascular Risk among Kidney Transplant Patients. Med Sci Sports Exerc. 2019 Jun;51(6):1154-1161. doi: 10.1249/MSS.0000000000001886.
- Derived from this study: PubMed 29760559Weinrauch LA, Claggett B, Liu J, Finn PV, Weir MR, Weiner DE, D'Elia JA. Smoking and outcomes in kidney transplant recipients: a post hoc survival analysis of the FAVORIT trial. Int J Nephrol Renovasc Dis. 2018 Apr 27;11:155-164. doi: 10.2147/IJNRD.S161001. eCollection 2018.
- Derived from this study: PubMed 28943384Weinrauch LA, D'Elia JA, Weir MR, Bunnapradist S, Finn PV, Liu J, Claggett B, Monaco AP. Infection and Malignancy Outweigh Cardiovascular Mortality in Kidney Transplant Recipients: Post Hoc Analysis of the FAVORIT Trial. Am J Med. 2018 Feb;131(2):165-172. doi: 10.1016/j.amjmed.2017.08.038. Epub 2017 Sep 21.
- Individual participant dataSharing planned: Yes. Individual patient data and samples are available at the NIDDK Central repository
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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.
Andrew Levey, M.D. study director
Tufts Medical Center
Myra A Carpenter, PhD principal investigator
University of North Carolina, Chapel Hill
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing High Dose Multivitamin and Low Dose Multivitamin in people with Chronic Kidney Disease and Cardiovascular Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 30 sites in 3 countries.
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 4 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: finished, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Canada, Brazil. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events (time frame: Up to 6 years (mean 4 years)). 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 NCT00064753, which also lists 11 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 18 Oct 2017.