Renal Transplantation Clinical Trial
Official title:
A 4-week, Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group Study to Compare the Gastrointestinal Safety and Tolerability of EC-MPS & MMF When Administered in Combination With Calcineurin Inhibitors in Renal Transplant Recipients Experiencing Gastrointestinal Intolerance
Verified date | July 2011 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated mycophenolate sodium (EC-MPS).
Status | Completed |
Enrollment | 400 |
Est. completion date | |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion criteria: - Males and females aged 18-75 years, Recipients of first or second cadaveric, living unrelated or living related kidney transplant - Recipients who are at least 4 weeks post renal transplantation with stable renal function, Patients currently receiving MMF (all dosages are allowed) and either cyclosporine USP (MODIFIED) or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 2 weeks prior to study start - Patients with at least one mild and/or moderate and/or severe upper or lower gastrointestinal (GI) complaints clearly associated with MMF therapy as determined by the treating physician. Additional mild GI complaints may coexist - Patients' immunosuppressive regimen other than steroids (doses and type) as well as medication for treatment of GI symptoms must be unchanged for at least 1 week prior to study start - Females of childbearing potential must have a negative pregnancy test prior to the inclusion period. The test should be performed locally at Baseline visit. If positive, the patient will not be included. Effective contraception must be used during the trial, and for 4 weeks following discontinuation of the study medication - Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained. Exclusion criteria: - Multi-organ transplant patients (e.g. kidney and pancreas) or previous transplant with any other organ different from kidney (second kidney transplant is allowed) - History of GI disorder (diarrhea, Gastroesophageal Reflux Disease (GERD), dyspepsia, Inflammatory Bowel Disease (IBD) or Irritable Bowel Syndrome (IBS) prior to transplantation - Evidence of any GI disorder induced by an infection, underlying medical condition, or concomitant medication other than MMF, Modification of GI medication or MMF dose within last 1 week - Evidence of graft rejection, treatment of acute rejection, or unstable renal function within 4 weeks prior to the Baseline visit, Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry - Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin - Pregnant or nursing (lactating) women, Women of child-bearing potential (WOCBP) not using an acceptable method of contraception such as: surgical sterilization, hormonal contraception, or double-barrier methods. - Contraception should be maintained throughout the study and for 4 weeks after study drug discontinuation. Other protocol defined inclusion/exclusion criteria may apply. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Piedmont Hospital | Atlanta | Georgia |
United States | Medical College of Georgia | Augusta | Georgia |
United States | Mid-Atlantic Nephrology Associates | Baltimore | Maryland |
United States | The Johns Hopkins Hospital | Baltimore | Maryland |
United States | University of Maryland | Baltimore | Maryland |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | UNC Chapel Hill | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | University of Chicago Medical Center | Chicago | Illinois |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | University Hospitals of Cleveland | Cleveland | Ohio |
United States | CRSTI | Dallas | Texas |
United States | Denver Nephrology | Denver | Colorado |
United States | University of Colorado Health Science Center | Denver | Colorado |
United States | Henry Ford Health System | Detroit | Michigan |
United States | St. John Hospital Medical Center | Detroit | Michigan |
United States | Baylor All Saints | Fort Worth | Texas |
United States | University of Florida College of Medicine | Gainesville | Florida |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | East Carolina University | Greenville | North Carolina |
United States | Pinnacle Health at Harrisburg Hospital | Harrisburg | Pennsylvania |
United States | Clarian Health Partners | Indianapolis | Indiana |
United States | St. Luke's Hospital of Kansas City | Kansas City | Missouri |
United States | Univ of KS Medical Ctr | Kansas City | Kansas |
United States | University of Kentucky Medical Center | Lexington | Kentucky |
United States | St. Baranabas Medical Center | Livingston | New Jersey |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
United States | David Geffen School of Medicine at UCLA | Los Angeles | California |
United States | National Institute of Transplantation | Los Angeles | California |
United States | University of Southern California | Los Angeles | California |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | The University of Tennessee Health Science Center | Memphis | Tennessee |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Yale University Transplantation | New Haven | Connecticut |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
United States | AKDHC Medical Research Services, LLC | Phoenix | Arizona |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | UC Davis Medical Center | Sacramento | California |
United States | University of Utah Hospitals and Clinics | Salt Lake City | Utah |
United States | University of California San Diego | San Diego | California |
United States | University of California, San Diego | San Diego | California |
United States | University of California | San Francisco | California |
United States | University of Washington | Seattle | Washington |
United States | Northwest Louisiana Nephrology Research | Shreveport | Louisiana |
United States | WKHS/LSUHSC Regional Transplant Center | Shreveport | Louisiana |
United States | Washington University School of Medicine | St. Louis | Missouri |
United States | Washington Hospital Transplant Research | Washington | District of Columbia |
United States | Wake Forest | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy | Response assessed using the Gastrointestinal Symptom Rating Scale (GSRS), designed to assess common symptoms with gastrointestinal (GI) disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The total score is an average of scores across all 15 items; a higher score indicates more GI symptoms. Response was defined as Day 30 improvement in the GSRS Total Score (change from baseline) of greater than or equal to 0.3. Minimum score is 1; maximum score is 7. | Baseline, Day 30 | Yes |
Secondary | Number of Participants With Biopsy-proven Acute Rejection (BPAR) and Treated Acute Rejection (TAR) | TAR was defined as an episode of acute rejection that was suspected on clinical grounds and was treated and confirmed by the investigator according to the patient's response to therapy. BPAR was defined a treated acute rejection that was confirmed by biopsy. A graft core biopsy was performed before or within 24 hours of initiation of anti-rejection therapy and was assessed by the pathologist at the center according to the BANFF 1997 criteria. |
30 days | No |
Secondary | Change From Baseline to Day 30 in the Severity of Gastrointestinal Symptoms Overall Total Score | The Severity Score for each GI symptom for each participant was calculated based on the physician's evaluation of current GI symptoms recorded at Baseline and Day 30. For each of the 16 individual GI symptoms the severity score ranged from 0 (absent) to 3 (severe). The Overall Total Score is the Mean of severity ratings of the 16 individual symptoms. | Baseline, Day 30 | Yes |
Secondary | Number of Participants With Reported Dose Changes or Interruption of Study Medication During the 30 Days of Treatment | The number of participants with reported dose changes or interruption of study medication during the 30 days of treatment.The most common dose adjustments were dose increases back to baseline levels following a decrease or interruption and decreases due to abnormal laboratory value Adverse Events (leucopenia, thrombocytopenia, neutropenia, or anemia). | 30 days | No |
Secondary | Change From Baseline in Lower and Upper GI Symptom Burden Measured by GI Symptom Rating Scale Score | This is reflected by the total score. The total score incorporates lower and upper GI elements. GSRS overall score is the mean of 15 individual GI symptom scores, each rated on a 7- point scale: 1 = no discomfort, 2= minor discomfort, 3 = mild discomfort, 4 = moderate discomfort, 5 = moderately sever discomfort, 6 = severe discomfort and 7 = very severe discomfort. Change from Baseline was calculated using ANCOVA, model includes GSRS, center and treatment group. | Baseline, Day 30 | No |
Secondary | Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment | The GSRS has five subscales (reflux, diarrhea, constipation, abdominal pain, indigestion) producing a mean subscale score ranging from 1 (=no discomfort at all) to 7 (very severe discomfort). The mean score at baseline (BL), the mean score at Day 30 and the mean Change from BL to Day 30 is presented for each of the five subscales. | Baseline to Day 30 | No |
Secondary | Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores | The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 different subscales (GI symptoms, emotional status, physical and social functions, and stress of medical treatment) that are rated on a 5-point scale from 0 to 4. The individual scores are summed to produce a total score of the 36 items for a total possible score of 0 to 144. Lower scores represent greater dysfunction. | Baseline, Day 30 | No |
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