NCT01707550

Brief Summary

This observational survey study will capture all renal transplant patients in Serbia who are currently receiving CellCept (mycophenolate mofetil) as part of their immunosuppressive protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
414

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

3 active sites

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

December 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

October 12, 2012

Last Update Submit

November 1, 2016

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (2)

  • Average dose of CellCept used in immunosuppressive protocols in Serbia

    9 months

  • Average dose of concomitant immunosuppressive drugs

    9 months

Secondary Outcomes (1)

  • Average duration of post-transplant period for patients in Serbia receiving CellCept

    9 months

Study Arms (1)

Cohort

Eligibility Criteria

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

Renal allograft recipients receiving CellCept as part of their immunosuppressive protocol

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Recipients of renal allograft
  • Patients receiving CellCept

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Belgrade, 11000, Serbia

Location

Unknown Facility

Niš, 18000, Serbia

Location

Unknown Facility

Novi Sad, 21000, Serbia

Location

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2012

First Posted

October 16, 2012

Study Start

December 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

SE(3)