End Stage Renal DiseaseNCT00951977
Live Kidney Donor Study - Cross-Sectional and Historical Cohort Study
An observational study of End Stage Renal Disease and Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
Kidney transplantation from living donors has been shown to carry many benefits over deceased donor transplantation. Because of benefits such as shorter waiting times and improved outcome for transplant recipients, living kidney donation accounts for an increasing number of kidney transplants nationwide. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Disease, Transplantation
- How many people
- 7,029 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2009to Jun 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants who have either donated a kidney or control subjects who are matched to have similar demographics and health condition a donor in the study.
Who may be able to join
- Underwent a unilateral donor nephrectomy between 5 and 50 years ago; but no later than June 30, 2005
- Alive at the time of study recruitment
Who cannot join
- Inability to contact donor
- Community Control Inclusion Criteria:
- Matched to donor as healthy subject with a medical encounter date within 5 years of the date of donation and alive at the time of study recruitment
- Same gender as donor
- Same race as donor
- Matched by age, not to differ by more than 2 years
Show all 11Show fewer
- Matched by BMI, not to differ by more than 5 kg/m^2 (JHS only)
- Community Control Exclusion Criteria:
- Inability to contact control participant
- Inability or unwillingness to provide informed consent
- Hypertension or identified Charlson comorbidity index variable diagnosed prior to or on the encounter date matched to the donor date of donation (REP only)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Minnesota
Minneapolis, Minnesota, 55455
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Kidney transplantation from living donors has been shown to carry many benefits over deceased donor transplantation. Because of benefits such as shorter waiting times and improved outcome for transplant recipients, living kidney donation accounts for an increasing number of kidney transplants nationwide. Most published studies about living kidney donation demonstrate that the procedure is safe, but they also emphasize concerns that long-term data on live donor outcomes are insufficient. The purpose of this study is to assess the long term outcomes and risks that may arise from living kidney donation.
Read the detailed description
Living donor transplants provide several advantages over deceased donor kidneys, including a shorter waiting time. Living donor grafts also appear to have a lower rate of delayed graft function and improved long-term recipient and graft survival. Most published studies of living kidney donation have supported that the donation process is relatively safe for the donor. However, these reports also emphasize concerns that comprehensive long-term data on U.S. live donor outcomes are insufficient. One concern is that current data may underestimate the true long-term morbidity and mortality of living kidney donation. Additionally, older studies might not apply to the current donor population that includes older and more obese individuals.
This is an observational study to look at the long term outcomes in living kidney donors. This study also seeks to find out if living kidney donors are at higher risk for certain conditions when compared to people of similar backgrounds who have not donated a kidney. Medical history, completed questionnaires, and blood and urine tests will be collected from donors and non donors. The compiled data from donors and non donors will be compared. Risks for diseases related to the kidney, heart, and blood vessels will be examined between the two groups. Quality of life and health insurance status will also be compared.
The study will be conducted in 2 phases. All donors who donated a kidney between 5 and 50 years ago at one of the three study transplant centers will be asked to take part in Phase 1. Phase 1 aims to collect limited medical information using a short questionnaire. Phase 2 will include Phase 1 donors who agree to further assessments and matched community control participants. Participants in Phase 2 will be asked to complete more in-depth questionnaires on health status and quality of life. Phase 2 also involves height, weight, and blood pressure measurements. Blood and urine will be collected for this study if the participant does not have the necessary tests within 3 years of study participation.
Seven thousand-eight hundred-sixty four (7864) previous kidney donors and about two thousand-five hundred (2500) control subjects will be asked to take part in this study. Participants will be recruited for this study over a 2.5.
- Conditions
- End Stage Renal Disease, Transplantation
- Keywords
- End Stage Renal Disease (ESRD), Transplantation, Living Kidney Donation, Kidney Transplant
- Medical subject headings
- Kidney Failure, Chronic
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 |
|---|---|---|
| Subjects who have formerly donated a kidney | Not described | |
| Matched community control Subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and incidence of hypertension, proteinuria, renal disease, and anemia
Measured: Since donation
Prevalence and incidence of cardiovascular disease as manifested by myocardial infarction (MI), heart failure (HF), stroke, and CABG/PTCA
Measured: Since donation
Quality of life and insurance status
Measured: Since donation
Secondary outcomes (10)
Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in black and white donors.
Measured: Since donation
Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in donors with open nephrectomy and in donors with laparoscopic nephrectomy.
Measured: Since donation
The operative morbidity in living kidney donors with open nephrectomy and in donors with laparoscopic nephrectomy.
Measured: Since donation
Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in standard living kidney donors and extended criteria donors.
Measured: Since donation
Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in donors more than 20 years since donation and in donors between 5 and 20 years since donation.
Measured: Since donation
The identification of donor family characteristics that correlated with living kidney donor risk for morbidity and renal disease.
Measured: Retrospective
Donor physical health and recipient post-transplant course as it correlates with positive QOL scores and negative QOL scores.
Measured: Since donation
Identify the predictors and correlates of donors' quality of life outcomes
Measured: Throughout study
Compare post-donation blood pressures, estimated glomerular filtration rate (GFR), urine protein levels and hemoglobin levels with those derived from population-based studies and matched community control participants
Measured: After donation
Recipient outcomes for donors participating in the study and those who decline to participate.
Measured: After donation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 7,029 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor
- Investigators
- Sandra J. Taler, MD, Principal investigator, Mayo Clinic, Division of Nephrology and Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951977
- Sponsor's protocol ID
- DAIT RELIVE-04
- Status last verified
- Mar 2017
- First submitted
- 31 Jul 2009
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Bieniasz M, Domagala P, Kwiatkowski A, Gozdowska J, Krzysztof O, Kieszek RA, Trzebicki J, Durlik M, Rowinski W, Chmura A. The assessment of residual kidney function after living donor nephrectomy. Transplant Proc. 2009 Jan-Feb;41(1):91-2. doi: 10.1016/j.transproceed.2008.08.160.
PubMed 19249485Hernandez D, Alvarez A, Armas A, Rufino M, Porrini E, Torres A. [Metabolic syndrome and live kidney donor: is this syndrome a contraindication to donation?]. Nefrologia. 2009;29(1):20-9. doi: 10.3265/Nefrologia.2009.29.1.20.1.en.full.pdf. Spanish.
PubMed 19240768Horvat LD, Shariff SZ, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. Global trends in the rates of living kidney donation. Kidney Int. 2009 May;75(10):1088-98. doi: 10.1038/ki.2009.20. Epub 2009 Feb 18.
PubMed 19225540Rowinski W, Chmura A, Wlodarczyk Z, Ostrowski M, Rutkowski B, Domagala P, Dziewanowski K, Matych J, Durlik M, Grenda R. Are we taking proper care of living donors? A follow-up study of living kidney donors in Poland and further management proposal. Transplant Proc. 2009 Jan-Feb;41(1):79-81. doi: 10.1016/j.transproceed.2008.08.140.
PubMed 19249481Taler SJ, Messersmith EE, Leichtman AB, Gillespie BW, Kew CE, Stegall MD, Merion RM, Matas AJ, Ibrahim HN; RELIVE Study Group. Demographic, metabolic, and blood pressure characteristics of living kidney donors spanning five decades. Am J Transplant. 2013 Feb;13(2):390-8. doi: 10.1111/j.1600-6143.2012.04321.x. Epub 2012 Nov 8.
PubMed 23137211Jacobs CL, Gross CR, Messersmith EE, Hong BA, Gillespie BW, Hill-Callahan P, Taler SJ, Jowsey SG, Beebe TJ, Matas AJ, Odim J, Ibrahim HN; RELIVE Study Group. Emotional and Financial Experiences of Kidney Donors over the Past 50 Years: The RELIVE Study. Clin J Am Soc Nephrol. 2015 Dec 7;10(12):2221-31. doi: 10.2215/CJN.07120714. Epub 2015 Oct 13.
PubMed 26463883Jowsey SG, Jacobs C, Gross CR, Hong BA, Messersmith EE, Gillespie BW, Beebe TJ, Kew C, Matas A, Yusen RD, Hill-Callahan M, Odim J, Taler SJ; RELIVE Study Group. Emotional well-being of living kidney donors: findings from the RELIVE Study. Am J Transplant. 2014 Nov;14(11):2535-44. doi: 10.1111/ajt.12906. Epub 2014 Oct 7.
PubMed 25293374Gross CR, Messersmith EE, Hong BA, Jowsey SG, Jacobs C, Gillespie BW, Taler SJ, Matas AJ, Leichtman A, Merion RM, Ibrahim HN; RELIVE Study Group. Health-related quality of life in kidney donors from the last five decades: results from the RELIVE study. Am J Transplant. 2013 Nov;13(11):2924-34. doi: 10.1111/ajt.12434. Epub 2013 Sep 6.
PubMed 24011252Noppakun K, Cosio FG, Dean PG, Taler SJ, Wauters R, Grande JP. Living donor age and kidney transplant outcomes. Am J Transplant. 2011 Jun;11(6):1279-86. doi: 10.1111/j.1600-6143.2011.03552.x. Epub 2011 May 12.
PubMed 21564530Messersmith EE, Gross CR, Beil CA, Gillespie BW, Jacobs C, Taler SJ, Merion RM, Jowsey SG, Leichtman AB, Hong BA; RELIVE Study Group. Satisfaction With Life Among Living Kidney Donors: A RELIVE Study of Long-Term Donor Outcomes. Transplantation. 2014 Dec 27;98(12):1294-300. doi: 10.1097/TP.0000000000000360.
PubMed 25136843
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Kidney Donor Study - Cross-Sectional and Historical Cohort Study
- ClinicalTrials.gov ID
- NCT00951977
- Acronym / sponsor ID
- DAIT RELIVE-04
- Conditions
- End Stage Renal Disease, Transplantation
- Keywords
- End Stage Renal Disease (ESRD), Transplantation, Living Kidney Donation, Kidney Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,029 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Health Resources and Services Administration (HRSA)
- Study start
- Oct 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 4 Aug 2009 (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.
Kidney transplantation from living donors has been shown to carry many benefits over deceased donor transplantation. Because of benefits such as shorter waiting times and improved outcome for transplant recipients, living kidney donation accounts for an increasing number of kidney transplants nationwide. Most published studies about living kidney donation demonstrate that the procedure is safe, but they also emphasize concerns that long-term data on live donor outcomes are insufficient. The purpose of this study is to assess the long term outcomes and risks that may arise from living kidney donation.
Detailed description
Living donor transplants provide several advantages over deceased donor kidneys, including a shorter waiting time. Living donor grafts also appear to have a lower rate of delayed graft function and improved long-term recipient and graft survival. Most published studies of living kidney donation have supported that the donation process is relatively safe for the donor. However, these reports also emphasize concerns that comprehensive long-term data on U.S. live donor outcomes are insufficient. One concern is that current data may underestimate the true long-term morbidity and mortality of living kidney donation. Additionally, older studies might not apply to the current donor population that includes older and more obese individuals.
This is an observational study to look at the long term outcomes in living kidney donors. This study also seeks to find out if living kidney donors are at higher risk for certain conditions when compared to people of similar backgrounds who have not donated a kidney. Medical history, completed questionnaires, and blood and urine tests will be collected from donors and non donors. The compiled data from donors and non donors will be compared. Risks for diseases related to the kidney, heart, and blood vessels will be examined between the two groups. Quality of life and health insurance status will also be compared.
The study will be conducted in 2 phases. All donors who donated a kidney between 5 and 50 years ago at one of the three study transplant centers will be asked to take part in Phase 1. Phase 1 aims to collect limited medical information using a short questionnaire. Phase 2 will include Phase 1 donors who agree to further assessments and matched community control participants. Participants in Phase 2 will be asked to complete more in-depth questionnaires on health status and quality of life. Phase 2 also involves height, weight, and blood pressure measurements. Blood and urine will be collected for this study if the participant does not have the necessary tests within 3 years of study participation.
Seven thousand-eight hundred-sixty four (7864) previous kidney donors and about two thousand-five hundred (2500) control subjects will be asked to take part in this study. Participants will be recruited for this study over a 2.5.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects who have formerly donated a kidney | – | – |
| Matched community control Subjects | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who have either donated a kidney or control subjects who are matched to have similar demographics and health condition a donor in the study.
Key inclusion criteria (2 listed)
- Underwent a unilateral donor nephrectomy between 5 and 50 years ago; but no later than June 30, 2005
- Alive at the time of study recruitment
Key exclusion criteria (11 listed)
- Inability to contact donor
- Matched to donor as healthy subject with a medical encounter date within 5 years of the date of donation and alive at the time of study recruitment
- Same gender as donor
- Same race as donor
- Matched by age, not to differ by more than 2 years
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
Prevalence and incidence of hypertension, proteinuria, renal disease, and anemia
Time frame: Since donation
Prevalence and incidence of cardiovascular disease as manifested by myocardial infarction (MI), heart failure (HF), stroke, and CABG/PTCA
Time frame: Since donation
Quality of life and insurance status
Time frame: Since donation
10 secondary outcomes
Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in black and white donors.
Time frame: Since donation
Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in donors with open nephrectomy and in donors with laparoscopic nephrectomy.
Time frame: Since donation
The operative morbidity in living kidney donors with open nephrectomy and in donors with laparoscopic nephrectomy.
Time frame: Since donation
Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in standard living kidney donors and extended criteria donors.
Time frame: Since donation
Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in donors more than 20 years since donation and in donors between 5 and 20 years since donation.
Time frame: Since donation
The identification of donor family characteristics that correlated with living kidney donor risk for morbidity and renal disease.
Time frame: Retrospective
Donor physical health and recipient post-transplant course as it correlates with positive QOL scores and negative QOL scores.
Time frame: Since donation
Identify the predictors and correlates of donors' quality of life outcomes
Time frame: Throughout study
Compare post-donation blood pressures, estimated glomerular filtration rate (GFR), urine protein levels and hemoglobin levels with those derived from population-based studies and matched community control participants
Time frame: After donation
Recipient outcomes for donors participating in the study and those who decline to participate.
Time frame: After donation
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 14 Mar 2017.
- Background: PubMed 19249485Bieniasz M, Domagala P, Kwiatkowski A, Gozdowska J, Krzysztof O, Kieszek RA, Trzebicki J, Durlik M, Rowinski W, Chmura A. The assessment of residual kidney function after living donor nephrectomy. Transplant Proc. 2009 Jan-Feb;41(1):91-2. doi: 10.1016/j.transproceed.2008.08.160.
- Background: PubMed 19240768Hernandez D, Alvarez A, Armas A, Rufino M, Porrini E, Torres A. [Metabolic syndrome and live kidney donor: is this syndrome a contraindication to donation?]. Nefrologia. 2009;29(1):20-9. doi: 10.3265/Nefrologia.2009.29.1.20.1.en.full.pdf. Spanish.
- Background: PubMed 19225540Horvat LD, Shariff SZ, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. Global trends in the rates of living kidney donation. Kidney Int. 2009 May;75(10):1088-98. doi: 10.1038/ki.2009.20. Epub 2009 Feb 18.
- Background: PubMed 19249481Rowinski W, Chmura A, Wlodarczyk Z, Ostrowski M, Rutkowski B, Domagala P, Dziewanowski K, Matych J, Durlik M, Grenda R. Are we taking proper care of living donors? A follow-up study of living kidney donors in Poland and further management proposal. Transplant Proc. 2009 Jan-Feb;41(1):79-81. doi: 10.1016/j.transproceed.2008.08.140.
- Results publication: PubMed 23137211Taler SJ, Messersmith EE, Leichtman AB, Gillespie BW, Kew CE, Stegall MD, Merion RM, Matas AJ, Ibrahim HN; RELIVE Study Group. Demographic, metabolic, and blood pressure characteristics of living kidney donors spanning five decades. Am J Transplant. 2013 Feb;13(2):390-8. doi: 10.1111/j.1600-6143.2012.04321.x. Epub 2012 Nov 8.
- Results publication: PubMed 26463883Jacobs CL, Gross CR, Messersmith EE, Hong BA, Gillespie BW, Hill-Callahan P, Taler SJ, Jowsey SG, Beebe TJ, Matas AJ, Odim J, Ibrahim HN; RELIVE Study Group. Emotional and Financial Experiences of Kidney Donors over the Past 50 Years: The RELIVE Study. Clin J Am Soc Nephrol. 2015 Dec 7;10(12):2221-31. doi: 10.2215/CJN.07120714. Epub 2015 Oct 13.
- Results publication: PubMed 25293374Jowsey SG, Jacobs C, Gross CR, Hong BA, Messersmith EE, Gillespie BW, Beebe TJ, Kew C, Matas A, Yusen RD, Hill-Callahan M, Odim J, Taler SJ; RELIVE Study Group. Emotional well-being of living kidney donors: findings from the RELIVE Study. Am J Transplant. 2014 Nov;14(11):2535-44. doi: 10.1111/ajt.12906. Epub 2014 Oct 7.
- Results publication: PubMed 24011252Gross CR, Messersmith EE, Hong BA, Jowsey SG, Jacobs C, Gillespie BW, Taler SJ, Matas AJ, Leichtman A, Merion RM, Ibrahim HN; RELIVE Study Group. Health-related quality of life in kidney donors from the last five decades: results from the RELIVE study. Am J Transplant. 2013 Nov;13(11):2924-34. doi: 10.1111/ajt.12434. Epub 2013 Sep 6.
- Results publication: PubMed 21564530Noppakun K, Cosio FG, Dean PG, Taler SJ, Wauters R, Grande JP. Living donor age and kidney transplant outcomes. Am J Transplant. 2011 Jun;11(6):1279-86. doi: 10.1111/j.1600-6143.2011.03552.x. Epub 2011 May 12.
- Results publication: PubMed 25136843Messersmith EE, Gross CR, Beil CA, Gillespie BW, Jacobs C, Taler SJ, Merion RM, Jowsey SG, Leichtman AB, Hong BA; RELIVE Study Group. Satisfaction With Life Among Living Kidney Donors: A RELIVE Study of Long-Term Donor Outcomes. Transplantation. 2014 Dec 27;98(12):1294-300. doi: 10.1097/TP.0000000000000360.
- National Institute of Allergy and Infectious Diseases (NIAID) websiteLink provided by the sponsor.
- National Heart, Lung, and Blood Institute websiteLink provided by the sponsor.
- National Kidney Registry websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for End Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
Sandra J. Taler, MD principal investigator
Mayo Clinic, Division of Nephrology and Hypertension
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 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 2 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: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
Prevalence and incidence of hypertension, proteinuria, renal disease, and anemia (time frame: Since donation). The study lists 3 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 NCT00951977, which also lists 10 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 14 Mar 2017.