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A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without Steroids (ADVANCE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01304836
First Posted: February 28, 2011
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
The purpose of this study is to focus on potential differences in the occurrence of new-onset Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of immunosuppressive treatment are compared.

Condition Intervention Phase
Kidney Transplantation Drug: Advagraf Drug: Mycophenolate Mofetil Drug: Simulect Drug: Corticosteroids Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Investigating New Onset Diabetes Mellitus in Kidney Transplant Recipients Receiving an Advagraf-Based Immunosuppressive Regimen With or Without Corticosteroids - A Multicenter, Two Arm, Randomized, Open Label Clinical Study

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Diagnosis of new onset Diabetes Mellitus as per ADA criteria at any point up to 24 weeks after kidney transplantation [ Time Frame: up to 6 months ]

Secondary Outcome Measures:
  • Efficacy failure using a composite endpoint consisting of graft loss, biopsy confirmed acute rejection or graft dysfunction [ Time Frame: up to 6 months ]
  • Positive Oral Glucose Tolerance Test [ Time Frame: 8 weeks ]
  • Repeat Positive Oral Glucose Tolerance Test [ Time Frame: 6 months ]
  • Renal function [ Time Frame: at 6 months ]
  • Acute Rejections [ Time Frame: up to 6 months ]
  • Biopsy confirmed acute rejections [ Time Frame: up to 6 months ]
  • Subject survival [ Time Frame: up to 6 months ]
  • Graft survival [ Time Frame: up to 6 months ]
  • Change from Baseline in HbA1C levels [ Time Frame: Baseline, week 12 and week 24 ]

Enrollment: 1166
Actual Study Start Date: January 22, 2011
Study Completion Date: May 22, 2013
Primary Completion Date: May 22, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 10 Days of Steroids
Advagraf + Basiliximab + MMF + Steroids (10 days)
Drug: Advagraf
oral
Other Names:
  • FK506E
  • modified release tacrolimus
Drug: Mycophenolate Mofetil
oral
Other Name: CellCept
Drug: Simulect
IV
Other Name: Basiliximab
Drug: Corticosteroids
IV & oral
Other Names:
  • prednisolone
  • methylprednisolone
Experimental: Optional Steroid bolus only
Advagraf + Basiliximab + MMF + Steroids (bolus only)
Drug: Advagraf
oral
Other Names:
  • FK506E
  • modified release tacrolimus
Drug: Mycophenolate Mofetil
oral
Other Name: CellCept
Drug: Simulect
IV
Other Name: Basiliximab
Drug: Corticosteroids
IV & oral
Other Names:
  • prednisolone
  • methylprednisolone

Detailed Description:
The primary objective of this study is to compare an Immunosuppressive regimen with 10 days of corticosteroids with a regimen with only an optional intra-op bolus of corticosteroids with regard to incidence of new onset Diabetes Mellitus as per the American Diabetic Association (ADA) criteria at any point up to 24 weeks after kidney transplantation.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • End stage kidney disease and a suitable candidate for primary

kidney transplantation or re-transplantation (unless the graft was

lost from rejection within one year)

  • Receiving a kidney transplant from a deceased or living (non

Human Leukocyte Antigen identical) donor with compatible AB0 blood type

  • Female subjects of childbearing potential must have a

negative serum or urine pregnancy test at enrollment and must

agree to maintain highly effective birth control during the study.

A highly effective method of birth control is defined as those

which result in a low failure rate (CPMP/ICH/286/95 modified)

of less than 1% per year when used consistently and correctly

such as implants, injectables, combined oral contraceptives,

some IUDs, sexual abstinence or vasectomized partner

Exclusion Criteria:

  • Receiving or having previously received an organ transplant

other than a kidney

  • Cold ischemia time of the donor kidney > 30 hours
  • Panel Reactive Antibody >20% (Highest level in 6 months prior to transplant)
  • Previous renal transplant lost within one year for immunological reasons
  • Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawal of support awaiting cardiac arrest)
  • Significant liver disease, defined as having continuously

elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin

levels ≥ 2 times the upper value of the normal range of the

investigational site or is receiving a graft from a hepatitis C or B

positive donor

  • Diagnosis of Diabetes Mellitus prior to transplantation (treated with prescribed medications or diet controlled) or where there is evidence of a previous positive Oral Glucose Tolerance Test (OGTT) in the patients medical history or previous diagnosis of gestational diabetes or pre-baseline HbA1C ≥6.5%
  • Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s).
  • Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation (e.g. for Lupus Disease, FSGN etc) other than minimal levels of immunosuppressant following failure of a previous transplantation without nephrectomy
  • Where Physician considers long term steroid treatment is necessary for the prevention of recurrent auto immune mediated renal disease or if the subject requires ongoing dosing with corticosteroids during the study for any other condition
  • Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
  • Pregnant woman or breast-feeding mother
  • Subject or donor known to be HIV positive
  • Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab, mycophenolate mofetil or any of the product excipients
  • Evidence of malignant disease within the last 5 years other than Basal Cell Carcinoma or Squamous Cell Carcinoma
  • Currently participating in another clinical trial and/or has taken an investigational drug within 28 days prior to randomization
  • Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
  • Unlikely to comply with the visits scheduled in the protocol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304836


  Show 100 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Europe Ltd.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01304836     History of Changes
Other Study ID Numbers: PMR-EC-1211
2010-019638-28 ( EudraCT Number )
First Submitted: February 3, 2011
First Posted: February 28, 2011
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.
URL: http://

Keywords provided by Astellas Pharma Inc:
Kidney
Diabetes Mellitus
Transplant
Immunosuppression

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Basiliximab
Methylprednisolone
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents


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