Estimated Glomerular Filtration Rate After Kidney Transplantation - the Formula MDRD, CKD-EPI or Cockroft-Gault?

Renal Function Disorder Clinical Trial

— eGFR  

Official title:

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443363
• Other study ID #: GFR/KTx/2015/04
• Status: Completed
• Phase: N/A
• First received: May 10, 2015
• Last updated: September 30, 2015
• Start date: April 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Renal Function Disorder
• Renal Insufficiency

Intervention

Other:
• Estimating of formula MDRD, CKD-EPI, Cockroft-Gault,

Device:
• Tanita BC 418- Bioelectrical impedance analysis
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).

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warsaw	Mazovian

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in estimating GFR using formula MDRD, CKD-EPI and Cockroft-Gault in short and long-term postoperative period.		1 day	No