Renal TransplantNCT00212979
Measuring Kidney Function in Kidney Transplantation
An observational study of Renal Transplant, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Kidney transplantation is the preferred treatment for permanent kidney failure. Following transplantation, the kidney function must be followed closely to detect problems so that investigations and appropriate treatment can be started early. Currently, function is monitored with the use of serum creatinine. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Renal Transplant
- What is being tested?
- non intervention study
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2004to Oct 2006
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than 18 years of age.
- At least 6 months post-renal transplantation.
Who cannot join
- Unable or unwilling to provide informed consent
- Pregnant or breastfeeding
- Acute rejection within the preceding three months
- Likely to die from another comorbid disease within the next three months
- Likely to require dialysis or repeat transplantation within the next three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Accurate Prediction of Renal Function in Kidney Transplant Recipients
Kidney transplantation is the preferred treatment for permanent kidney failure. Following transplantation, the kidney function must be followed closely to detect problems so that investigations and appropriate treatment can be started early. Currently, function is monitored with the use of serum creatinine. In clinical trials involving kidney transplant recipients, markers of kidney function, such as serum creatinine, are increasingly being used as outcomes to evaluate new treatments. However, serum creatinine is not very accurate or sensitive at detecting change in kidney transplant function. Newer methods of evaluating kidney function, such as the Modification of Diet in Renal Disease (MDRD) equation and cystatin C, are known to be accurate markers of function in patients with non-transplant kidney disease. This study will compare the MDRD estimate and cystatin C estimate of kidney function with an accepted method (radioisotope clearance study) of measuring true kidney function in 250 renal transplant patients. Each patient will have 2 measurements made at least 3 months apart to determine the accuracy and responsiveness to change over time for the MDRD equation and cystatin C. If the results demonstrate that these new methods are accurate then clinical care and research studies involving transplant patients will be greatly enhanced. Patients and physicians would have a simple test that could detect problems earlier and more precisely monitor response to treatment leading to improved outcomes for renal transplant recipients.
Read the detailed description
Background and Hypothesis:
Short-term outcomes in renal transplantation, such as the acute rejection rate, have improved dramatically over the past decade. Unfortunately, this success has made it more difficult to evaluate new therapies in kidney transplantation. Markers of kidney function, such as serum creatinine and creatinine clearance, are now being used to evaluate kidney transplant function. However, serum creatinine and creatinine clearance have many limitations and correlate poorly with the glomerular filtration rate (GFR). The Modification of Diet in Renal Disease (MDRD) formula has been shown to be very accurate at predicting GFR in patients with kidney disease who don't have renal transplants. Cystatin C, a novel marker of renal function, has also been shown to be accurate in transplant and non-transplant patients. However, the MDRD formula and cystatin C have not been properly validated in a large sample of renal transplant recipients.
Objectives:
The primary objective of this study is to determine if the MDRD formula accurately predicts GFR in renal transplant recipients. Secondary objectives of the study will determine whether: the MDRD formula is responsive to change in GFR over time, cystatin C accurately predicts GFR, or the MDRD formula is more accurate than other estimating equations in renal transplant recipients.
Research Plan:
A prospective cohort design will be used. Eligible adult renal transplant recipients at least 3 months post-transplantation will have serum creatinine, albumin, urea, cystatin C, 24-hour urine excretion of urea, 24-hour urine excretion of creatinine, 24-hour urine excretion of protein and GFR measured at study entry and at least 3 months later. GFR will be measured using 99Tc-DTPA. Estimates of the GFR will be made with the MDRD equation and other estimating equations. Renal function will also be assessed by measuring the urinary creatinine clearance and the combined urea and creatinine clearance. The primary analysis will determine the accuracy (proportion of GFR estimates that lie within 30% of measured GFR) of the MDRD equation. Secondary analyses will be performed to determine the bias (mean difference between the measured GFR and estimated GFR) and precision (standard deviation of the difference between the measured and estimated GFR) of the MDRD equation as well as the bias and precision of the change in GFR over twelve months. Similar analyses will be performed for cystatin C and other estimating equations.
Importance of Study:
New methods to accurately measure GFR are needed for both clinical care and research studies involving renal transplant recipients. As new therapies and immunosuppressive strategies become available, a simple and accurate means (such as the MDRD equation) to assess response to therapy will be invaluable. Markers of kidney function (serum creatinine, predicted GFR) are already being used in clinical trials involving renal transplant recipients without appropriate evaluation. The proper validation of equations to predict GFR in transplant recipients must be carried before they can be widely accepted in practice or for use in research protocols. If this study shows that the MDRD equation (or other marker of kidney function) is accurate in transplant patients then we can confidently move forward and use these validated measures of GFR in patient care and future research studies.
- Conditions
- Renal Transplant
- Being tested
- non intervention study
- Keywords
- glomerular filtration rate, cystatin C, creatinine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non intervention studyOther
| Study group | Role | What they receive |
|---|---|---|
| non intervention study | Not described Receives: Other: non intervention study |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantStudies 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
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor
- Investigators
- Greg A Knoll, MD, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212979
- Sponsor's protocol ID
- PSI Grant R03-59
- Other IDs
- REB Protocol #2003435-01H
- Status last verified
- Feb 2009
- First submitted
- 13 Sep 2005
- Last updated
- 31 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accurate Prediction of Renal Function in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT00212979
- Acronym / sponsor ID
- PSI Grant R03-59
- Conditions
- Renal Transplant
- Keywords
- glomerular filtration rate, cystatin C, creatinine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Apr 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 21 Sep 2005 (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 is the preferred treatment for permanent kidney failure. Following transplantation, the kidney function must be followed closely to detect problems so that investigations and appropriate treatment can be started early. Currently, function is monitored with the use of serum creatinine. In clinical trials involving kidney transplant recipients, markers of kidney function, such as serum creatinine, are increasingly being used as outcomes to evaluate new treatments. However, serum creatinine is not very accurate or sensitive at detecting change in kidney transplant function. Newer methods of evaluating kidney function, such as the Modification of Diet in Renal Disease (MDRD) equation and cystatin C, are known to be accurate markers of function in patients with non-transplant kidney disease. This study will compare the MDRD estimate and cystatin C estimate of kidney function with an accepted method (radioisotope clearance study) of measuring true kidney function in 250 renal transplant patients. Each patient will have 2 measurements made at least 3 months apart to determine the accuracy and responsiveness to change over time for the MDRD equation and cystatin C. If the results demonstrate that these new methods are accurate then clinical care and research studies involving transplant patients will be greatly enhanced. Patients and physicians would have a simple test that could detect problems earlier and more precisely monitor response to treatment leading to improved outcomes for renal transplant recipients.
Detailed description
Background and Hypothesis:
Short-term outcomes in renal transplantation, such as the acute rejection rate, have improved dramatically over the past decade. Unfortunately, this success has made it more difficult to evaluate new therapies in kidney transplantation. Markers of kidney function, such as serum creatinine and creatinine clearance, are now being used to evaluate kidney transplant function. However, serum creatinine and creatinine clearance have many limitations and correlate poorly with the glomerular filtration rate (GFR). The Modification of Diet in Renal Disease (MDRD) formula has been shown to be very accurate at predicting GFR in patients with kidney disease who don't have renal transplants. Cystatin C, a novel marker of renal function, has also been shown to be accurate in transplant and non-transplant patients. However, the MDRD formula and cystatin C have not been properly validated in a large sample of renal transplant recipients.
Objectives:
The primary objective of this study is to determine if the MDRD formula accurately predicts GFR in renal transplant recipients. Secondary objectives of the study will determine whether: the MDRD formula is responsive to change in GFR over time, cystatin C accurately predicts GFR, or the MDRD formula is more accurate than other estimating equations in renal transplant recipients.
Research Plan:
A prospective cohort design will be used. Eligible adult renal transplant recipients at least 3 months post-transplantation will have serum creatinine, albumin, urea, cystatin C, 24-hour urine excretion of urea, 24-hour urine excretion of creatinine, 24-hour urine excretion of protein and GFR measured at study entry and at least 3 months later. GFR will be measured using 99Tc-DTPA. Estimates of the GFR will be made with the MDRD equation and other estimating equations. Renal function will also be assessed by measuring the urinary creatinine clearance and the combined urea and creatinine clearance. The primary analysis will determine the accuracy (proportion of GFR estimates that lie within 30% of measured GFR) of the MDRD equation. Secondary analyses will be performed to determine the bias (mean difference between the measured GFR and estimated GFR) and precision (standard deviation of the difference between the measured and estimated GFR) of the MDRD equation as well as the bias and precision of the change in GFR over twelve months. Similar analyses will be performed for cystatin C and other estimating equations.
Importance of Study:
New methods to accurately measure GFR are needed for both clinical care and research studies involving renal transplant recipients. As new therapies and immunosuppressive strategies become available, a simple and accurate means (such as the MDRD equation) to assess response to therapy will be invaluable. Markers of kidney function (serum creatinine, predicted GFR) are already being used in clinical trials involving renal transplant recipients without appropriate evaluation. The proper validation of equations to predict GFR in transplant recipients must be carried before they can be widely accepted in practice or for use in research protocols. If this study shows that the MDRD equation (or other marker of kidney function) is accurate in transplant patients then we can confidently move forward and use these validated measures of GFR in patient care and future research studies.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non intervention study | – | Other: non intervention study |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Greater than 18 years of age.
- At least 6 months post-renal transplantation.
Key exclusion criteria (5 listed)
- Unable or unwilling to provide informed consent
- Pregnant or breastfeeding
- Acute rejection within the preceding three months
- Likely to die from another comorbid disease within the next three months
- Likely to require dialysis or repeat transplantation within the next three 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 |
|---|---|---|
| non intervention study | Other | non intervention study |
Primary outcome
Not reported in the source record.
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 31 Mar 2016.
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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.
Greg A Knoll, MD principal investigator
OHRI
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 Renal Transplant, run by Ottawa Hospital Research Institute at 1 site 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 2 inclusion and 5 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 31 Mar 2016. 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 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.
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.
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 31 Mar 2016.