- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02443363
Estimated Glomerular Filtration Rate After Kidney Transplantation - the Formula MDRD, CKD-EPI or Cockroft-Gault? (eGFR)
September 30, 2015 updated by: Łukasz Czyżewski, Medical University of Warsaw
Estimated Glomerular Filtration Rate After Kidney Transplantation - the Formula Modification of Diet in Renal Disease (MDRD), Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or Cockroft-Gault?
The study included 300 patients who are post-kidney transplantation (> 3 months and <10 years).
An analysis of body composition using bioelectrical impedance, calculated BMI and serum creatinine was determined.
Glomerular filtration rate (GFR) was calculated using the formula CKD-EPI, Modification of Diet in Renal Disease (MDRD) and Cockroft-Gault.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
170
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Mazovian
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Warsaw, Mazovian, Poland, 02-091
- Medical University of Warsaw
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A total of 300 consecutive patients after kidney transplantation admitted to routine visit in Transplant Centre
Description
Inclusion Criteria:
- give voluntary consent to participate in the study
- functioning graft longer than 3 months to 10 years
- no clinical cardiovascular disease during the 6 months preceding entry
- stable graft function- glomerular filtration rate > 30 ml/min/1.73 m2, creatinine concentration <2.5 mg/dl
Exclusion Criteria:
- not meet the above criteria
- episode of illness (for example: infection)
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients After Kidney Transplantation
A total of 300 consecutive patients admitted to routine visit in Transplant Centre with functioning graft longer than 3 months to 10 years
|
The device measured the size of total body water (TBW), fat mass (FM%), visceral fat%, fat free mass (FFM), and basal metabolic rate (BMR) (kcal).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Differences in estimating GFR using formula MDRD, CKD-EPI and Cockroft-Gault in short and long-term postoperative period.
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
May 10, 2015
First Submitted That Met QC Criteria
May 10, 2015
First Posted (Estimate)
May 13, 2015
Study Record Updates
Last Update Posted (Estimate)
October 2, 2015
Last Update Submitted That Met QC Criteria
September 30, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- GFR/KTx/2015/04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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