Measurement of Patient Reported Outcomes in Renal Transplant Patients With And Without Gastrointestinal (GI) Symptoms (PROGIS)

Novartis

Status: Completed

Conditions: GI Symptoms Severity; Kidney Transplantation

Study type: Observational

Funder types: Industry

Identifiers

NCT01300416

CERL080AMY02

Details and patient eligibility

About

This study will access the GI complaints on patients reported outcomes and to determine the improvement in quality of life in patients.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient received kidney transplant at least 1 month prior to study with MMF as a part of the treatment for at least 2 weeks.
• Eligible to convert to myfortic because of GI complaints or not currently experiencing GI complaints and stable on current immunosuppressive regimen.
• At least 18 years of age;
• Willing to provide written informed consent; and
• Able to meet all study requirements including completing paper questionnaires and completing two study visits.

Exclusion criteria

• GI symptoms assumed or known not be caused by MPA therapy and have recent acute rejection at least 1 week prior to the study.
• Breast-feeding or pregnant woman.
• Patients with psychiatric illness.
• Underlying acute medical intervention or hospitalization
• Receiving investigational drug within 30days prior to study.

Trial design

101 participants in 2 patient groups

With Gastro-Intestinal (GI) symptoms

Without GI symptoms