MULTICENTER, OBSERVATIONAL, LONG-TERM STUDY ON THE IMPACT OF THE THERAPEUTIC DECISION TAKEN IN PATIENTS RECEIVING A TRANSPLANT OF SOLID ORGAN, WHO WILL RECEIVE SANDIMMUN NEORAL IN CIRCUMSTANCES OF NORMAL CLINICAL PRACTICE.

Not Applicable

• Conditions: -Z94; Z94

• Registration Number: PER-048-02
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-07-16
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Man or woman who is a recipient of a de novo transplant or who is in the maintenance phase.
• The prescribed and prescribed immunosuppression regimen should be based on the use of Neoral.
• The patient has given written informed consent (if required or if appropriate).

Exclusion Criteria

• Patients who are currently receiving a non-patented medication
research or planning to participate in a study with a research drug.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:• Clinical and laboratory parameters used to evaluate the function of the graft<br>• Occurrence of acute rejection<br>• Chronic rejection<br>• Graft loss (moment and main cause)<br>• Death (moment and cause)<br>Measure:Maintenance of an optimal graft function and in the necessary medication adjustments<br>Timepoints:Months 1, 3, 6 and 12<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Late graft function, cardiovascular diseases, infections, neoplasms and other relevant complications that affect the graft or specific body systems.<br>Measure:Postransplant-specific complications that affect the function of the graft or the outcome of the patient.<br>Timepoints:Months 1, 3, 6 and 12<br>