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

Completed

• Conditions: GI Symptoms Severity; Kidney Transplantation

• Registration Number: NCT01300416
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-18
• Study First Posted: 2011-02-21
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-23
• Last Update Posted: 2016-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine if GI symptoms severity and health related quality of life of patients has improved after being converted from MMF to EC-MPS due to GI complaints.	4-6 weeks

Secondary Outcome Measures

Name	Time	Method
To identify and evaluate quality of life and impact on symptom severity based on patients perception.	4-6 weeks

Trial Locations

Locations (9)

Hospital Pulau Pinang; 🇲🇾 Pulau Pinang, Malaysia

Hospital Kuala Lumpur; 🇲🇾 Kuala Lumpur, Malaysia

Hospital Tengku Ampuan Afzan; 🇲🇾 Kuantan, Malaysia

Hospital Serdang; 🇲🇾 Serdang, Malaysia

Hospital Umum Sarawak; 🇲🇾 Kuching, Malaysia

Hospital Selayang; 🇲🇾 Selayang, Malaysia

Hospital Universiti Kebangsaan Malaysia; 🇲🇾 Cheras, Malaysia

Hospital Queen Elizabeth; 🇲🇾 Kota Kinabalu, Malaysia

Hospital Raja Perempuan Zainab II; 🇲🇾 Kota Bharu, Malaysia