Trial Outcomes & Findings for Erythropoietin (EPO) and Ischemia-reperfusion After Kidney Transplantation (NCT NCT00425698)

NCT ID: NCT00425698

Last Updated: 2010-09-28

Results Overview

Estimated glomerular filtration rate (eGFR) was assessed using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)equation

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 88 participants
• Primary outcome timeframe: 42 days after transplantation
• Results posted on: 2010-09-28

Participant Flow

February 2007 until May 2009. Single recruitment site was the Hannover Medical School in Hannover, Germany

420 patients screened, 88 patients finally enrolled, other patients not enrolled because of age<18 years, living-related kidney transplantation, high pre-immunisation, multiple transplantation, participation in other studies, no interest for participation or withdraw of consent

Participant milestones

Measure	Erythropoietin	Placebo
Overall Study STARTED	44	44
Overall Study COMPLETED	41	42
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Erythropoietin	Placebo
Overall Study Adverse Event	3	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Erythropoietin (EPO) and Ischemia-reperfusion After Kidney Transplantation

Baseline characteristics by cohort

Measure	Erythropoietin n=44 Participants	Placebo n=44 Participants	Total n=88 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	44 Participants n=7 Participants	88 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	54 years STANDARD_DEVIATION 2 • n=5 Participants	50 years STANDARD_DEVIATION 2 • n=7 Participants	52 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment Germany	44 participants n=5 Participants	44 participants n=7 Participants	88 participants n=5 Participants

PRIMARY outcome

Timeframe: 42 days after transplantation

Estimated glomerular filtration rate (eGFR) was assessed using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)equation

Outcome measures

Measure	Erythropoietin n=44 Participants	Placebo n=44 Participants
Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR)	47 ml/min Standard Deviation 28	46 ml/min Standard Deviation 22

SECONDARY outcome

Timeframe: 6 month after transplantation

Estimated glomerular filtration rate (eGFR) was assessed using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)equation

Outcome measures

Outcome data not reported

Adverse Events

Erythropoietin

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Erythropoietin n=44 participants at risk	Placebo n=44 participants at risk
Renal and urinary disorders graft loss	6.8% 3/44 • Number of events 3 • 42 days	0.00% 0/44 • 42 days
Respiratory, thoracic and mediastinal disorders embolism	0.00% 0/44 • 42 days	2.3% 1/44 • Number of events 1 • 42 days

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. Danilo Fliser

Saarland University Medical Centre

Phone: (49) 6841

Email: indfli@uks.eu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place