NCT02443363

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 2, 2015

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

May 10, 2015

Last Update Submit

September 30, 2015

Conditions

Renal Function Disorder

Outcome Measures

Primary Outcomes (1)

  • Differences in estimating GFR using formula MDRD, CKD-EPI and Cockroft-Gault in short and long-term postoperative period.

    1 day

Study Arms (1)

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

Other: Estimating of formula MDRD, CKD-EPI, Cockroft-Gault,Device: Tanita BC 418- Bioelectrical impedance analysis

Interventions

Estimating of formula MDRD, CKD-EPI, Cockroft-Gault,OTHER
Patients After Kidney Transplantation
Tanita BC 418- Bioelectrical impedance analysisDEVICE

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).

Patients After Kidney Transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 300 consecutive patients after kidney transplantation admitted to routine visit in Transplant Centre

You may qualify if:

  • 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

You may not qualify if:

  • not meet the above criteria
  • episode of illness (for example: infection)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw

Warsaw, Mazovian, 02-091, Poland

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Łukasz Czyżewski

Study Record Dates

First Submitted

May 10, 2015

First Posted

May 13, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 2, 2015

Record last verified: 2015-09

Locations

PL(1)