Chronic Kidney DiseaseNCT01158911
Uric Acid and Long-term Outcomes in Chronic Kidney Disease
An observational study of Chronic Kidney Disease, run by Tufts Medical Center at 1 site in United States.
Trial summary
Patients in the earlier stages of Chronic kidney disease (CKD) are at risk both for the development of end-stage renal disease (ESRD) (define by the requirement for dialysis or kidney transplantation) and development of cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 838 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 838 participants of the randomized arm of the Modification of Diet in Renal Disaese (MDRD) Study conducted between 1989-1993
Who may be able to join
- between 18 and 70 years of age
- with serum creatinine of 1.2 to 7 mg/dl in women and 1.4 to 7 mg/dl in men
Who cannot join
- pregnancy
- Type I diabetes
- insulin dependent type II diabetes
- renal artery stenosis
- proteinuria greater than 10mg/day
- mean arterial pressure greater than 125 mmHg
- prior kidney transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Uric Acid Promote Progression of Kidney Disease and Development of Cardiovascular Disease in Patients With Chronic Kidney Disease?
Patients in the earlier stages of Chronic kidney disease (CKD) are at risk both for the development of end-stage renal disease (ESRD) (define by the requirement for dialysis or kidney transplantation) and development of cardiovascular disease (CVD). Although controversial, there is literature to suggest that uric acid may play a role in the progression of kidney disease and development of cardiovascular disease (CVD). The Modification of Diet in Renal Disease (MDRD) Study was a randomized controlled trial in patients with CKD, which examined the effects of dietary protein restriction and strict blood pressure control on progression of non-diabetic CKD. Extensive data on risk factors for progression of kidney disease and development of CVD are available, as is long term follow up. 838 of the 840 patients who were randomized have uric acid levels measured at baseline. The aims of the present study are to examine the determinants of uric acid in cross sectional analysis at baseline, to determine the association between uric acid and development of ESRD, and the association of uric acid with all-cause and CVD mortality.
Level of kidney function will be a major determinant of uric acid levels independent of other risk factors.
Read more
Level of uric acid will be associated with development of ESRD independent of level of kidney function and other risk factors.
Uric Acid levels will be associated with both all-cause and CVD mortality independent of kidney function and other risk factors.
- Conditions
- Chronic Kidney Disease
- Keywords
- kidney disease, uric acid, outcomes, cardiovascular, mortality, kidney failure, Uric Acid levels in patients with Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases, Renal Insufficiency
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 |
|---|---|---|
| non-diabetic Chronic Kidney disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney Failure
Secondary outcomes (1)
CVD and All-Cause Mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 838 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158911
- Sponsor's protocol ID
- 4530
- Status last verified
- Oct 2006
- First submitted
- 6 Jul 2010
- Last updated
- 8 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Uric Acid Promote Progression of Kidney Disease and Development of Cardiovascular Disease in Patients With Chronic Kidney Disease?
- ClinicalTrials.gov ID
- NCT01158911
- Acronym / sponsor ID
- 4530
- Conditions
- Chronic Kidney Disease
- Keywords
- kidney disease, uric acid, outcomes, cardiovascular, mortality, kidney failure, Uric Acid levels in patients with Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 838 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Study start
- Feb 2007
- First posted
- 8 Jul 2010 (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.
Patients in the earlier stages of Chronic kidney disease (CKD) are at risk both for the development of end-stage renal disease (ESRD) (define by the requirement for dialysis or kidney transplantation) and development of cardiovascular disease (CVD). Although controversial, there is literature to suggest that uric acid may play a role in the progression of kidney disease and development of cardiovascular disease (CVD). The Modification of Diet in Renal Disease (MDRD) Study was a randomized controlled trial in patients with CKD, which examined the effects of dietary protein restriction and strict blood pressure control on progression of non-diabetic CKD. Extensive data on risk factors for progression of kidney disease and development of CVD are available, as is long term follow up. 838 of the 840 patients who were randomized have uric acid levels measured at baseline. The aims of the present study are to examine the determinants of uric acid in cross sectional analysis at baseline, to determine the association between uric acid and development of ESRD, and the association of uric acid with all-cause and CVD mortality.
Level of kidney function will be a major determinant of uric acid levels independent of other risk factors.
Level of uric acid will be associated with development of ESRD independent of level of kidney function and other risk factors.
Uric Acid levels will be associated with both all-cause and CVD mortality independent of kidney function and other risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-diabetic Chronic Kidney disease | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 838 participants of the randomized arm of the Modification of Diet in Renal Disaese (MDRD) Study conducted between 1989-1993
Key inclusion criteria (2 listed)
- between 18 and 70 years of age
- with serum creatinine of 1.2 to 7 mg/dl in women and 1.4 to 7 mg/dl in men
Key exclusion criteria (7 listed)
- pregnancy
- Type I diabetes
- insulin dependent type II diabetes
- renal artery stenosis
- proteinuria greater than 10mg/day
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
Kidney Failure
1 secondary outcome
CVD and All-Cause Mortality
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 8 Jul 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 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 8 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney Failure. 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 8 Jul 2010.