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CompletedNCT01056835Updated May 27, 2015

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

A Phase 3 interventional study of prostaglandin I2 analogue in Chronic Allograft Nephropathy, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-05-27.

Sponsored by Seoul National University Hospital · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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

02

Conditions studied

  • Chronic Allograft Nephropathy

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03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

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Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • prevalent renal transplant recipients 2 years after transplantation
  • no history of acute rejection
  • stable renal function

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • No intervention
    control

    Drug: prostaglandin I2 analogue

Interventions

  • Drugprostaglandin I2 analogue
06

What researchers measure

Primary outcomes

  1. graft pathology, serum creatinine, creatinine clearance, eGFR

    Time frame: 1 year after drug administration

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01056835
Lead sponsor
Seoul National University Hospital
Responsible party
Jongwon Ha (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jan 26, 2010
Start date
Jun 2009
Primary completion
Dec 2013
Completion
Jun 2014
Last update
May 27, 2015

Study contacts

Jongwon Ha, MD, PhD
principal investigator · Seoul National University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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