Impact of Myfortic on Gastrointestinal (GI) Prophylaxis in Maintenance Renal Transplant Patients

NCT00905242 | Completed Phase 4

• 1 other identifier: CERL080A-US41
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether maintenance renal transplant patients receiving Myfortic can reduce or discontinue GI prophylaxis medications.

Conditions

Kidney Transplantation

Keywords

Kidney Transplantation; Gastrointestinal Agents

Outcome Measures

Primary Outcomes (1)

• To determine the success (% of patients) in discontinuing GI medications over the 90-day period or also, % of patients able to maintain reduced doses of GI medications over the 90-day period.

  90 days

Secondary Outcomes (1)

• To evaluate the cost effectiveness of discontinuing GI medications in transplant recipients.

  90 days

Interventions

GI medication DRUG

Patients on daily dosing were asked to discontinue their GI medication at baseline. Patients on twice daily dosing were asked to reduce GI medication to once a day at baseline and asked to discontinue GI medication at day 30.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have completed the parent study, US02.
• Patients on GI medications.
• Patients currently receiving Myfortic (all dosages are allowed), neoral or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least two weeks.
• Patients with and/or without mild GI complaints (e.g. upper abdominal pain, dyspepsia, anorexia, nausea, vomiting) with or without diarrhea.
• Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

You may not qualify if:

• Evidence of graft rejection or treatment of acute rejection within 14 days prior to Baseline visit.
• Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry.
• Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
• Patients with thrombocytopenia (\<75,000/mm3), with an absolute neutrophil count of \<1,500/mm3 and/or leukocytopenia (\<4,000/mm3), and/or hemoglobin \<9.0g/dL prior to enrollment.
• Presence of clinically significant infection requiring continued therapy, severe diarrhea or active peptic ulcer disease that would interfere with the appropriate conduct of the study.
• Evidence of severe liver disease (incl. abnormal liver profile i.e. AST, ALT or total bilirubin \>or= 3 times ULN).
• Evidence of drug and/or alcohol abuse.
• Inability to self-administer the GSRS, GIQLI and PGWBI questionnaires.
• Patients receiving \>10mg/day prednisone dose.

Sponsors & Collaborators

• East Carolina University: lead
• Novartis: collaborator

Study Sites (1)

Brody School of Medicine at East Carolina University

Greenville, North Carolina, 27834, United States

Location

Study Officials

• Paul Bolin, MD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: March 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: May 20, 2009

Record last verified: 2009-05

Locations

US (1)