Effects of PGI2 Analogue Use on the Development of Chroni... | NCT01056835

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

NCT01056835

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

May 27, 2015Estimated

Enrollment

40Estimated

Phase

Phase 3

Conditions

Chronic Allograft Nephropathy

Interventions

prostaglandin I2 analogue

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2013Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jan 24, 2010

First Submission Date that Met QC Criteria

Jan 24, 2010

First Posted Date

Jan 26, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2015

Last Update Posted Date

May 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Label	Type	Description	Intervention Names
control	No Intervention		Drug: prostaglandin I2 analogue

Name	Type	Description	Arm Group Labels	Other Names
prostaglandin I2 analogue	Drug		control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
graft pathology, serum creatinine, creatinine clearance, eGFR		1 year after drug administration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jongwon Ha, MD, PhD	Seoul National University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea