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

Kidney Transplantation Clinical Trial

— PROGIS  

Official title:

Open, Multi-centre, Non-interventional, Observational Study to Characterize the Impact That GI Complaints Have on Patient-reported Outcomes in Patients Who Have Had a Renal Transplant. Patients Will be Evaluated at Visit 1 and Then Again After 4 (+2) Weeks (Visit 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300416
• Other study ID #: CERL080AMY02
• Status: Completed
• Phase: N/A
• First received: February 17, 2011
• Last updated: March 23, 2016
• Start date: July 2010
• Est. completion date: July 2012

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health Malaysia
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• GI Symptoms Severity
• Kidney Transplantation

Locations

Country	Name	City	State
Malaysia	Hospital Universiti Kebangsaan Malaysia	Cheras
Malaysia	Hospital Raja Perempuan Zainab II	Kota Bharu
Malaysia	Hospital Queen Elizabeth	Kota Kinabalu
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur
Malaysia	Hospital Tengku Ampuan Afzan	Kuantan
Malaysia	Hospital Umum Sarawak	Kuching
Malaysia	Hospital Pulau Pinang	Pulau Pinang
Malaysia	Hospital Selayang	Selayang
Malaysia	Hospital Serdang	Serdang

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To identify and evaluate quality of life and impact on symptom severity based on patients perception.		4-6 weeks	No