ImmunosuppressionPhase 4NCT02953873

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

A Phase 4 study testing Tacrolimus Extended Release Capsule, Mycophenolate mofetil and Prednisone in people with Immunosuppression, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Immunosuppression
What is being tested?: Tacrolimus Extended Release Capsule, Mycophenolate mofetil and Prednisone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 5 May 2017to 14 Dec 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients Converted From Twice-daily Tacrolimus

Read the 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.

Conditions: Immunosuppression
Being tested: Tacrolimus Extended Release Capsule, Mycophenolate mofetil, Prednisone, Mycophenolate Sodium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tacrolimus Extended Release CapsuleDrug
Also called Astagraf XL
goal trough 5 - 12ng/mL
Mycophenolate mofetilDrug
Also called Cellcept
≥500mg twice a day
PrednisoneDrug
Also called Corticosteroids, Methylprednisolone
goal dose 5mg daily
Mycophenolate SodiumDrug
Also called Myfortic
≥360mg twice a day

Study groups in NCT02953873
Study group	Role	What they receive
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 Receives: Drug: Tacrolimus Extended Release Capsule; Drug: Mycophenolate mofetil; Drug: Prednisone; Drug: Mycophenolate Sodium

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose-normalized Trough
Difference in dose-normalized trough at steady state before and after conversion from tacrolimus IR to Astagraf XL®
Measured: Baseline to 3 months post-conversion

Secondary outcomes (4)

Total Daily Dose
Difference in Total Daily Dose necessary for steady state therapeutic goal
Measured: Baseline to 3 months post conversion
Weight-Based Dose Requirement
Weight-based dose requirements to reach therapeutic goal pre- and post-conversion
Measured: Baseline to 3 months post conversion
Number of Days to Reach Therapeutic Trough Goal
Days to reach therapeutic goal after conversion
Measured: Baseline to 3 months post conversion
Dose Modifications
Number of dose modifications from baseline to 3 months post-conversion.
Measured: Baseline to 3 months post conversion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 201714 Dec 2018

First posted3 Nov 2016 (estimated)
Study start5 May 2017
Primary completion10 Sep 2018
Study completion14 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ImmunosuppressionStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02953873
Sponsor's protocol ID: 00061221
Status last verified: Dec 2019
First submitted: 1 Nov 2016
Last updated: 26 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: The data will not be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
Active, not recruitingPhase 1
CD4^LVFOXP3 in Participants With IPEX
IPEX

All Immunosuppression trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients Converted From Twice-daily Tacrolimus
ClinicalTrials.gov ID: NCT02953873
Acronym / sponsor ID: 00061221
Conditions: Immunosuppression
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: Astellas Pharma Inc
Study start: 5 May 2017 (actual)
Primary completion: 10 Sep 2018 (actual)
Study completion: 14 Dec 2018 (actual)
First posted: 3 Nov 2016 (estimated)
Results: Posted 26 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Conversion Arm	Other	Drug: Tacrolimus Extended Release Capsule, Drug: Mycophenolate mofetil, Drug: Prednisone, Drug: Mycophenolate SodiumTacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tacrolimus Extended Release CapsuleAlso: Astagraf XLgoal trough 5 - 12ng/mL	Drug	Conversion Arm
Mycophenolate mofetilAlso: Cellcept≥500mg twice a day	Drug	Conversion Arm
PrednisoneAlso: Corticosteroids, Methylprednisolonegoal dose 5mg daily	Drug	Conversion Arm
Mycophenolate SodiumAlso: Myfortic≥360mg twice a day	Drug	Conversion Arm

Primary outcome

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®

4 secondary outcomes

Total Daily Dose
Time frame: Baseline to 3 months post conversion
Weight-Based Dose Requirement
Time frame: Baseline to 3 months post conversion
Number of Days to Reach Therapeutic Trough Goal
Time frame: Baseline to 3 months post conversion
Dose Modifications
Time frame: Baseline to 3 months post conversion

Results and safety

Results posted to the registry on 26 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Conversion Arm	25	25

Primary outcome: Dose-normalized Trough

Time frame: Baseline to 3 months post-conversion. Median (Inter-Quartile Range). Unit: ng/dL

Measure	Conversion Arm n = 25
Pre-Conversion Dose Trough	0.59 (0.50 to .76)
Post-Conversion Dose Trough	0.44 (0.39 to 0.80)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected over 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Conversion Arm	1 of 25 (4%)	19 of 25 (76%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. The data will not be shared.

Related trials for Immunosuppression

Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
Active, not recruitingPhase 1
CD4^LVFOXP3 in Participants With IPEX
IPEX

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James Fleming, PharmD principal investigator

Medicual U of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-normalized Trough (time frame: Baseline to 3 months post-conversion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02953873.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.