Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Adele Rike-Shields, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01336296
First received: October 28, 2010
Last updated: May 20, 2016
Last verified: May 2016

October 28, 2010
May 20, 2016
September 2010
April 2014   (final data collection date for primary outcome measure)
Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) at 6 Months [ Time Frame: Incidence at 3, 6 and 12 months post transplant ] [ Designated as safety issue: No ]

Incidence of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) at 6 months. The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:

As with humoral rejection, there are both acute & chronic forms:

The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:

Class IA: there is at least 25% of parenchymal showing interstitial infiltration and foci of moderate tubulitis (defined as a certain number of immune cells present in tubular cross-sections).

Class IB: just like Class IA except there is more severe tubulitis.

Class IIA: there is mild-to-moderate intimal arteritis.

Class IIB: there is severe intimal arteritis comprising at least 25% of the lumenal area.

Class III: there is transmural (e.g. the full vessel wall thickness) arteritis.

Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Incidence of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) at 6 months.
Complete list of historical versions of study NCT01336296 on ClinicalTrials.gov Archive Site
  • Severity of Acute Rejection by Banff '97 Criteria [ Time Frame: Severity 1 year post transplant ] [ Designated as safety issue: No ]

    Severity of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) at 1 year. The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:

    As with humoral rejection, there are both acute & chronic forms:

    The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:

    Class IA: there is at least 25% of parenchymal showing interstitial infiltration and foci of moderate tubulitis (defined as a certain number of immune cells present in tubular cross-sections).

    Class IB: just like Class IA except there is more severe tubulitis.

    Class IIA: there is mild-to-moderate intimal arteritis.

    Class IIB: there is severe intimal arteritis comprising at least 25% of the lumenal area.

    Class III: there is transmural (e.g. the full vessel wall thickness) arteritis.

  • Difference in Renal Function [ Time Frame: Difference at 1 month, 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
    Difference in renal function between groups at listed time points assessed by mean serum creatinine. Increased serum creatinine could indicate worsening renal function. A "normal" serum creatinine range for the transplant population varies by patient, but a typical range for Scr would be 1-2 mg/dL.
  • Incidence of Chronic Alloantibody Rejection or Chronic Allograft Arteriopathy by Banff '97 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The Banff features suggestive of chronic rejection were: a) chronic transplant glomerulopathy: Glomerular basement membrane duplication and mesangial cell proliferation, and b) vasculopathy: Fibrous intimal thickening often with fragmentation of internal elastic lamina. Chronic changes in the interstitium (ci), tubules (ct), vessels (cv), and glomerulus (cg) were likewise graded into 0, 1, 2, and 3. The severity of interstitial fibrosis and tubular atrophy, as also chronic transplant glomerulopathy and vasculopathy were used to grade chronic allograft changes.
  • Number of Patients Requiring Anti-lymphocyte Therapy for Acute Rejection [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Severity of Acute Rejection by Banff '97 Criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Severity of acute rejection by Banff '97 Criteria. Acute cellular rejection Acute antibody mediated (humoral) rejection Proportion of patients requiring anti-lymphocyte therapy for acute rejection Incidence of chronic alloantibody rejection or chronic allograft arteriopathy by Banff '97 Criteria Change in creatinine clearance Urinary protein Incidence of denovo donor specific antibodies (DSA) Incidence of death, graft loss, DGF, infection, and post-transplant malignancies.

Patient and allograft survival

Not Provided
Not Provided
 
Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients
A 12-month, Prospective, Randomized, Dual Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of Myfortic® (Mycophenolic Acid) Loading Regimens in Combination With Thymoglobulin® [Anti-thymocyte Globulin (Rabbit)] or Simulect® (Basiliximab) Induction and Prograf® (Tacrolimus) in Early Corticosteroid Withdrawal
This study is specifically designed to determine whether the initiation of Myfortic 2 weeks prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy in low to moderate risk patients. Specifically, the addition of Myfortic pretransplant to Simulect induction will be compared to standard Myfortic therapy with Thymoglobulin induction starting at the time of transplant in kidney transplant recipients.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplant Recipients
Drug: mycophenolic acid
Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant.
Other Name: Myfortic
  • Active Comparator: Myfortic preload
    Initiation of mycophenolic acid (Myfortic) 2 weeks prior to transplantation (with Simulect induction at time of transplant)
    Intervention: Drug: mycophenolic acid
  • Active Comparator: Myfortic standard
    mycophenolic acid (Myfortic) at time of transplant with Thymoglobulin induction
    Intervention: Drug: mycophenolic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients capable of understanding the purposes and risks of the study.
  • Patients who can give written informed consent, and who are willing and able to participate in the full course of the study.
  • Women of childbearing potential must have a negative serum pregnancy test within the last 48 hours prior to receiving study medication.
  • Women of childbearing potential must use two reliable forms of contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. Effective contraception must be used before beginning study drug therapy, for the duration of the study and for 6 weeks following completion of the study.

Exclusion Criteria:

  • Patients who are recipients of a multiple organ transplant or if the patient previously received and organ transplant.
  • Patients who are recipients of A-B-O incompatible transplants, all complement-dependent cytotoxicity (CDC) crossmatch positive transplants.
  • Sensitized patients [most recent anti-Human Leukocyte Antigens (HLA) Class I panel reactive antibody (PRA) ≥ 25% by a CDC-based assay].
  • Recipient or donor is known to be seropositive for hepatitis C virus (HCV) or B virus (HBV) except for hepatitis B surface antibody positive.
  • Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
  • Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
  • Patients with thrombocytopenia (<75,000/mm3 ), with an absolute neutrophil count of < 1,500/mm3); and/or leucopoenia (< 2,500/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.
  • Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
  • Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil, enteric-coated mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.
  • Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication; diabetic patients with previously diagnosed diabetic gastroenteropathy, or patients with active peptic ulcer disease.
  • Patient is receiving chronic steroid therapy at the time of transplant.
  • Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin.
  • Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
  • Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
  • Inability to cooperate or communicate with the investigator.
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01336296
Myfortic Preload
No
Not Provided
Not Provided
Adele Rike-Shields, University of Cincinnati
University of Cincinnati
Novartis Pharmaceuticals
Principal Investigator: Adele Shields, Pharm.D. University of Cincinnati
University of Cincinnati
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP