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

NCT02953873 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 00061221
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunosuppression

Outcome Measures

Primary Outcomes (1)

• Dose-normalized Trough

  Difference in dose-normalized trough at steady state before and after conversion from tacrolimus IR to Astagraf XL®

  Baseline to 3 months post-conversion

Secondary Outcomes (4)

• Total Daily Dose

  Baseline to 3 months post conversion

• Weight-Based Dose Requirement

  Baseline to 3 months post conversion

• Number of Days to Reach Therapeutic Trough Goal

  Baseline to 3 months post conversion

• Dose Modifications

  Baseline to 3 months post conversion

Study Arms (1)

Conversion Arm

OTHER

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; Drug: Mycophenolate mofetil; Drug: Prednisone; Drug: Mycophenolate Sodium

Interventions

Tacrolimus Extended Release Capsule DRUG

goal trough 5 - 12ng/mL

Also known as: Astagraf XL

Conversion Arm

Mycophenolate mofetil DRUG

≥500mg twice a day

Also known as: Cellcept

Conversion Arm

Prednisone DRUG

goal dose 5mg daily

Also known as: Corticosteroids, Methylprednisolone

Conversion Arm

Mycophenolate Sodium DRUG

≥360mg twice a day

Also known as: Myfortic

Conversion Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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
• Currently enrolled in an investigational drug trial
• History of a non-renal organ transplant
• History of acute cellular rejection within 1 month prior to randomization
• An increase in serum creatinine by \> 20% in the 2 weeks prior to randomization
• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Interventions

Tacrolimus; Mycophenolic Acid; Prednisone; Adrenal Cortex Hormones; Methylprednisolone

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Prednisolone; Pregnadienetriols

Results Point of Contact

• Title: Caitlin Schaffner
• Organization: Medical University of South Carolina

schaffne@musc.edu

843-792-7558

Study Officials

• James Fleming, PharmD

  Medicual U of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 3, 2016
• Study Start: May 5, 2017
• Primary Completion: September 10, 2018
• Study Completion: December 14, 2018
• Last Updated: December 26, 2019
• Results First Posted: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)