Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy

Chronic Allograft Nephropathy Clinical Trial

Official title:

Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056835
• Other study ID #: Beraprost-01
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2010
• Last updated: May 24, 2015
• Start date: June 2009
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of Prostaglandin I2 analogue use on the development of chronic allograft nephropathy and changes in allograft function in prevalent renal transplant recipients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• prevalent renal transplant recipients 2 years after transplantation

• no history of acute rejection

• stable renal function

Exclusion Criteria:

• history of biopsy-proven chronic allograft nephropathy

• history of biopsy-proven CNI nephrotoxicity

• history of biopsy-proven or clinical acute rejection

• unstable trough level of CNI or extremely low level of CNI

• bleeding tendency(+)

• pregnancy or pregnant-willing

• anticoagulation(+)

• antiplatelet agent (+)

• significant comorbidity(+): Acute coronary syndrome, pneumonia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Allograft Nephropathy
• Kidney Diseases

Intervention

Drug:
• prostaglandin I2 analogue

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	graft pathology, serum creatinine, creatinine clearance, eGFR		1 year after drug administration