Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients

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.
 
ClinicalTrials.gov Identifier: NCT02953873
Recruitment Status : Completed
First Posted : November 3, 2016
Results First Posted : December 26, 2019
Last Update Posted : December 26, 2019
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
James N. Fleming, Medical University of South Carolina

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Compare the difference in dose-normalized trough and total daily dose necessary to reach the steady state therapeutic goal after conversion from tacrolimus IR to Astagraf XL® in African American kidney transplant recipients.

Condition or disease Intervention/treatment Phase
Immunosuppression Drug: Tacrolimus Extended Release Capsule Drug: Mycophenolate mofetil Drug: Prednisone Drug: Mycophenolate Sodium Phase 4

Detailed Description:
The purpose of this study is to compare the difference in medication dosage and total daily dose necessary of Astagraf XL® in order to reach therapy goal, when taken with other medications that are routinely used for kidney transplantation, which may stop the development of a substance that can cause long-term damage to the transplanted kidney. African American kidney transplant patients aged 18 and above who are underwent a kidney transplant are eligible to participate. The duration of the study is 3 months.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients Converted From Twice-daily Tacrolimus
Actual Study Start Date : May 5, 2017
Actual Primary Completion Date : September 10, 2018
Actual Study Completion Date : December 14, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Conversion Arm
Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily
 Drug: Tacrolimus Extended Release Capsule
goal trough 5 - 12ng/mL
Other Name: Astagraf XL

Drug: Mycophenolate mofetil
≥500mg twice a day
Other Name: Cellcept

Drug: Prednisone
goal dose 5mg daily
Other Names:
  • Corticosteroids
  • Methylprednisolone

Drug: Mycophenolate Sodium
≥360mg twice a day
Other Name: Myfortic


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Dose-normalized Trough [ Time Frame: Baseline to 3 months post-conversion ]
    Difference in dose-normalized trough at steady state before and after conversion from tacrolimus IR to Astagraf XL®


Secondary Outcome Measures :
  1. Total Daily Dose [ Time Frame: Baseline to 3 months post conversion ]
    Difference in Total Daily Dose necessary for steady state therapeutic goal

  2. Weight-Based Dose Requirement [ Time Frame: Baseline to 3 months post conversion ]
    Weight-based dose requirements to reach therapeutic goal pre- and post-conversion

  3. Number of Days to Reach Therapeutic Trough Goal [ Time Frame: Baseline to 3 months post conversion ]
    Days to reach therapeutic goal after conversion

  4. Dose Modifications [ Time Frame: Baseline to 3 months post conversion ]
    Number of dose modifications from baseline to 3 months post-conversion.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 18 years of age
  2. Signed informed consent
  3. African American race
  4. History of a solitary renal transplant
  5. Stable tacrolimus dose for at least 2 weeks prior to randomization

Exclusion Criteria:

  1. A condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject
  2. Currently enrolled in an investigational drug trial
  3. History of a non-renal organ transplant
  4. History of acute cellular rejection within 1 month prior to randomization
  5. An increase in serum creatinine by > 20% in the 2 weeks prior to randomization
  6. Maintenance immunosuppression that does not consist of tacrolimus IR given twice daily, mycophenolate mofetil > 1000mg TDD or mycophenolate sodium > 720mg TDD, and prednisone ≥ 5mg daily
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02953873


Locations
Layout table for location information
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Astellas Pharma Inc
Investigators
Layout table for investigator information
Principal Investigator: James Fleming, PharmD Medicual U of South Carolina
  Study Documents (Full-Text)

Documents provided by James N. Fleming, Medical University of South Carolina:
Study Protocol and Statistical Analysis Plan  [PDF] December 12, 2017

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: James N. Fleming, Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02953873    
Other Study ID Numbers: 00061221
First Posted: November 3, 2016    Key Record Dates
Results First Posted: December 26, 2019
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will not be shared.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Mycophenolic Acid
Prednisone
Methylprednisolone
Tacrolimus
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents