Complication of TransplantPhase 4NCT02014103

Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients

A Phase 4 study testing Prograf, Tacrolimus, Sandoz and Tacrolimus, Reddy Laboratory in people with Complication of Transplant, run by University of Cincinnati 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

The prospective study will compare the relative bioavailability at steady-state pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Complication of Transplant
What is being tested?: Prograf, Tacrolimus, Sandoz and Tacrolimus, Reddy Laboratory
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 1 siteUnited States
Study dates: Mar 2015to Aug 2015
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

18 years or older
Able to participate and willing to give written informed consent/ assent/ consent by parent or legal guardian and to comply with the study visits and restrictions.
Subject who has received a primary or secondary transplant.
Subject who is at least 6 months post-transplant and on a stable dose of tacrolimus as defined by physician, one tacrolimus trough level within the physician defined target range within past 6 months and one additional trough level during the screening period within 30% of the physician defined target range.
BMI less than or equal to 40.

Who cannot join

Evidence of any acute rejection
Subjects who require dialysis within 6 months prior to study entry
Recipients of multiple organ transplants
Subjects who have tested positive for HBsAG or HIV, or who are recipients of organ from donors who are known to be HBsAG or HIV positive. Virology screening at the time of transplant.
HepC positive subjects with liver biopsy proven recurrent disease considered relevant by physician oversight.
Subjects with any severe medical condition requiring acute or chronic treatment that in the investigator's opinion would interfere with study participation

Show all 20Show fewer

History of malignancy, treated or untreated, with the past 2 years with the exception of carcinoma in situ or excised basal cell carcinoma, or hepatocellular carcinoma prior to transplant.
GFR ≤ 35 ml/min measured as estimated using the MDRD4 formula
Subjects with AST, ALT, total bilirubin ≥ 3 X ULN or other evidence of severe liver disease
Subjects with white blood cell (WBC) count ≤2,000/ mm3 or with thrombocytopenia (platelet count ≤ 75,000/ mm3), with an absolute neutrophil count of ≤ 1,500/ mm3 or hemoglobin <8g/dL)
Subjects with clinically significant infections, requiring therapy, which, in the investigator's opinion, would interfere with the objectives of the study
Other mental or physical conditions which in the investigator's opinion, are considered clinically significant
Presence of intractable immunosuppressant complications or side effects resulting in dose adjustment of tacrolimus
Subjects who have been exposed to an investigational therapy within 30 days prior to enrollment or 5 half-lives of the investigational product, whichever is greater.
An anticipated change in the immunosuppressive regimen during subject participation other than that required by the protocol
Subject with severe GI disturbance or diarrhea which could interfere with tacrolimus absorption
Severe diabetic gastroparesis
Initiation of any medications that could interfere with tacrolimus blood levels, including OTC medications, herbal supplements, grapefruit or grapefruit juice.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive BhCG laboratory test (> 5 mIU/mL)
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are: 1) women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner; 2)women whose partners have been sterilized by vasectomy or 3)using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs); periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Cincinnati Medical Center
Cincinnati, Ohio, 45267

Other trials in United States

About this study

Official title: Evaluation of Clinical and Safety Outcomes Associated With Conversion From Brand-Name to Generic Tacrolimus Products in High Risk Transplant Recipients

Read the detailed description

Comparison of the relative bioavailability and steady-state pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients. Six tacrolimus formulations will be tested and each patient will receive each formulation once. As we proposed to test bioequivalence in the steady-state, patients will receive the test formulations for one week prior to pharmacokinetic evaluation. The pharmacokinetic evaluation will incorporate limited sampling strategies with a focus on fully characterizing the Cmax out to hour 4 post dose. Subsequent PK sampling and trough blood concentrations will be monitored on a daily basis using dried blood spots that the study subjects will collect by themselves at home. It will be critical that the patients are adherent to their test medication to ensure that they have reached steady state. This will be monitored using test diaries, pill counts and MEMS caps (Medication Event Monitoring System (MEMS), AARDEX Corp, Palo Alto, CA. Bioequivalence will be tested using average bioequivalence metrics. A combination of limited sampling strategy and dry spot analysis in combination with population pharmacokinetic modeling will be utilized to fully characterize the PK profile of these formulations.

Conditions: Complication of Transplant
Being tested: Prograf, Tacrolimus, Sandoz, Tacrolimus, Reddy Laboratory, Tacrolimus, Mylan, Tacrolimus, Accord
Keywords: bioequivalence, tacrolimus, transplant, CYP3A5 expressors/non expressors

What participants receive

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

PrografDrug
Administration of each formulation will be determined by sequence.
Tacrolimus, SandozDrug
Also called Sandoz tacrolimus
Administration of each formulation will be determined by sequence.
Tacrolimus, Reddy LaboratoryDrug
Also called Reddy's Laboratory tacrolimus
Administration of each formulation will be determined by sequence.
Tacrolimus, MylanDrug
Also called Mylan tacrolimus
Administration of each formulation will be determined by sequence.
Tacrolimus, AccordDrug
Also called Accord Healthcare tacrolimus
Administration of each formulation will be determined by sequence.
Tacrolimus, Pancea Biotech LimitedDrug
Also called Panacea Biotech Limited tacrolimus
Administration of each formulation will be determined by sequence.

Study groups in NCT02014103
Study group	Role	What they receive
Sequence 1	Active comparator	Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 1: Formulation Sandoz, Panacea, Accord, Mylan, Dr. Reddy's, Astellas Patients will be receiving the same tacrolimus dose identified at baseline for each formulation. Receives: Drug: Prograf; Drug: Tacrolimus, Sandoz; Drug: Tacrolimus, Reddy Laboratory; Drug: Tacrolimus, Mylan; Drug: Tacrolimus, Accord; Drug: Tacrolimus, Pancea Biotech Limited
Sequence 2	Active comparator	Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 2: Formulation Accord, Sandoz, Dr. Reddy's, Panacea, Astellas, Mylan Patients will be receiving the same tacrolimus dose identified at baseline for each formulation. Receives: Drug: Prograf; Drug: Tacrolimus, Sandoz; Drug: Tacrolimus, Reddy Laboratory; Drug: Tacrolimus, Mylan; Drug: Tacrolimus, Accord; Drug: Tacrolimus, Pancea Biotech Limited
Sequence 3	Active comparator	Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 3: Formulation Dr. Reddys, Accord, Astellas, Sandoz, Mylan, Panacea Patients will be receiving the same tacrolimus dose identified at baseline for each formulation. Receives: Drug: Prograf; Drug: Tacrolimus, Sandoz; Drug: Tacrolimus, Reddy Laboratory; Drug: Tacrolimus, Mylan; Drug: Tacrolimus, Accord; Drug: Tacrolimus, Pancea Biotech Limited
Sequence 4	Active comparator	Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 4: Formulation Astellas, Dr. Reddy's, Mylan, Accord, Panacea, Sandoz Patients will be receiving the same tacrolimus dose identified at baseline for each formulation. Receives: Drug: Prograf; Drug: Tacrolimus, Sandoz; Drug: Tacrolimus, Reddy Laboratory; Drug: Tacrolimus, Mylan; Drug: Tacrolimus, Accord; Drug: Tacrolimus, Pancea Biotech Limited
Sequence 5	Active comparator	Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 5: Formulation Mylan, Astellas, Panacea, Dr. Reddy's, Sandoz, Accord Patients will be receiving the same tacrolimus dose identified at baseline for each formulation. Receives: Drug: Prograf; Drug: Tacrolimus, Sandoz; Drug: Tacrolimus, Reddy Laboratory; Drug: Tacrolimus, Mylan; Drug: Tacrolimus, Accord; Drug: Tacrolimus, Pancea Biotech Limited
Sequence 6	Active comparator	Patients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 6: Formulation Panacea, Mylan, Sandoz, Astellas, Accord, Dr. Reddy's Patients will be receiving the same tacrolimus dose identified at baseline for each formulation. Receives: Drug: Prograf; Drug: Tacrolimus, Sandoz; Drug: Tacrolimus, Reddy Laboratory; Drug: Tacrolimus, Mylan; Drug: Tacrolimus, Accord; Drug: Tacrolimus, Pancea Biotech Limited

What is being measured

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

Compare AUC 0-12hr of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Report the geometric mean and 95% confidence interval for AUC 0-12hr (ng*hr/ml) for each formulation in expressor and non expressor transplant recipients
Measured: Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.
Compare Cmax of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Report the geometric mean and 95% confidence interval for Cmax (ng/ml) for each formulation in expressor and non expressor transplant recipients
Measured: Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.

Secondary outcomes (1)

To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Conduct safety lab testing specific to transplanted organ function and clinical assessments for adverse events.
Measured: Assessed at baseline and weekly for 6 weeks at each pharmacokinetic profile

Timeline

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

Mar 2015Aug 2015

First posted18 Dec 2013 (estimated)
Study startMar 2015
Primary completionAug 2015
Study completionAug 2015

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 Complication of TransplantStudies of the same condition, open and under way.
More trials run by University of CincinnatiThe 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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02014103
Sponsor's protocol ID: 13-223-SOL-00102
Other IDs: FDA
Status last verified: Oct 2024
First submitted: 21 Oct 2013
Last updated: 15 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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?

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All Complication of Transplant trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Clinical and Safety Outcomes Associated With Conversion From Brand-Name to Generic Tacrolimus Products in High Risk Transplant Recipients
ClinicalTrials.gov ID: NCT02014103
Acronym / sponsor ID: 13-223-SOL-00102
Conditions: Complication of Transplant
Keywords: bioequivalence, tacrolimus, transplant, CYP3A5 expressors/non expressors
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: University of CincinnatiUniversity, hospital or other
Collaborators: University of Colorado, Denver, Children's Hospital Medical Center, Cincinnati
Study start: Mar 2015
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 18 Dec 2013 (estimated)
Results: Posted 15 Oct 2024

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: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence 1	Active comparator	Drug: Prograf, Drug: Tacrolimus, Sandoz, Drug: Tacrolimus, Reddy Laboratory, Drug: Tacrolimus, Mylan, Drug: Tacrolimus, Accord, Drug: Tacrolimus, Pancea Biotech LimitedPatients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 1: Formulation Sandoz, Panacea, Accord, Mylan, Dr. Reddy's, Astellas Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
Sequence 2	Active comparator	Drug: Prograf, Drug: Tacrolimus, Sandoz, Drug: Tacrolimus, Reddy Laboratory, Drug: Tacrolimus, Mylan, Drug: Tacrolimus, Accord, Drug: Tacrolimus, Pancea Biotech LimitedPatients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 2: Formulation Accord, Sandoz, Dr. Reddy's, Panacea, Astellas, Mylan Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
Sequence 3	Active comparator	Drug: Prograf, Drug: Tacrolimus, Sandoz, Drug: Tacrolimus, Reddy Laboratory, Drug: Tacrolimus, Mylan, Drug: Tacrolimus, Accord, Drug: Tacrolimus, Pancea Biotech LimitedPatients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 3: Formulation Dr. Reddys, Accord, Astellas, Sandoz, Mylan, Panacea Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
Sequence 4	Active comparator	Drug: Prograf, Drug: Tacrolimus, Sandoz, Drug: Tacrolimus, Reddy Laboratory, Drug: Tacrolimus, Mylan, Drug: Tacrolimus, Accord, Drug: Tacrolimus, Pancea Biotech LimitedPatients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 4: Formulation Astellas, Dr. Reddy's, Mylan, Accord, Panacea, Sandoz Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
Sequence 5	Active comparator	Drug: Prograf, Drug: Tacrolimus, Sandoz, Drug: Tacrolimus, Reddy Laboratory, Drug: Tacrolimus, Mylan, Drug: Tacrolimus, Accord, Drug: Tacrolimus, Pancea Biotech LimitedPatients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 5: Formulation Mylan, Astellas, Panacea, Dr. Reddy's, Sandoz, Accord Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.
Sequence 6	Active comparator	Drug: Prograf, Drug: Tacrolimus, Sandoz, Drug: Tacrolimus, Reddy Laboratory, Drug: Tacrolimus, Mylan, Drug: Tacrolimus, Accord, Drug: Tacrolimus, Pancea Biotech LimitedPatients will be randomized to a sequence of administration of the various 6 tacrolimus formulations. Sequence 6: Formulation Panacea, Mylan, Sandoz, Astellas, Accord, Dr. Reddy's Patients will be receiving the same tacrolimus dose identified at baseline for each formulation.

Who may qualify

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

Key inclusion criteria (5 listed)

18 years or older
Able to participate and willing to give written informed consent/ assent/ consent by parent or legal guardian and to comply with the study visits and restrictions.
Subject who has received a primary or secondary transplant.
Subject who is at least 6 months post-transplant and on a stable dose of tacrolimus as defined by physician, one tacrolimus trough level within the physician defined target range within past 6 months and one additional trough level during the screening period within 30% of the physician defined target range.
BMI less than or equal to 40.

Key exclusion criteria (20 listed)

Evidence of any acute rejection
Subjects who require dialysis within 6 months prior to study entry
Recipients of multiple organ transplants
Subjects who have tested positive for HBsAG or HIV, or who are recipients of organ from donors who are known to be HBsAG or HIV positive. Virology screening at the time of transplant.
HepC positive subjects with liver biopsy proven recurrent disease considered relevant by physician oversight.

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
PrografAdministration of each formulation will be determined by sequence.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
Tacrolimus, SandozAlso: Sandoz tacrolimusAdministration of each formulation will be determined by sequence.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
Tacrolimus, Reddy LaboratoryAlso: Reddy's Laboratory tacrolimusAdministration of each formulation will be determined by sequence.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
Tacrolimus, MylanAlso: Mylan tacrolimusAdministration of each formulation will be determined by sequence.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
Tacrolimus, AccordAlso: Accord Healthcare tacrolimusAdministration of each formulation will be determined by sequence.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
Tacrolimus, Pancea Biotech LimitedAlso: Panacea Biotech Limited tacrolimusAdministration of each formulation will be determined by sequence.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6

Primary outcome

Compare AUC 0-12hr of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Time frame: Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.
Report the geometric mean and 95% confidence interval for AUC 0-12hr (ng*hr/ml) for each formulation in expressor and non expressor transplant recipients
Compare Cmax of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Time frame: Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.
Report the geometric mean and 95% confidence interval for Cmax (ng/ml) for each formulation in expressor and non expressor transplant recipients

1 secondary outcome

To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Time frame: Assessed at baseline and weekly for 6 weeks at each pharmacokinetic profile

Results and safety

Results posted to the registry on 15 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Expressors	35	26
Non-expressors	36	27

Primary outcome: Compare AUC 0-12hr of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients

Time frame: Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.. Mean (95% Confidence Interval). Unit: ng*hr/ml

Measure	Expressors n = 26	Non-expressors n = 27
Accord	112.35 (95.83 to 131.72)	92.37 (81.14 to 105.15)
Astellas	97.04 (82.77 to 113.77)	84.16 (73.93 to 95.81)
Dr. Reddys	110.63 (85.83 to 117.98)	83.96 (73.75 to 95.58)
Mylan	96.83 (82.59 to 113.53)	85.53 (75.13 to 97.37)
Panacea	100.58 (85.79 to 117.92)	89.38 (78.51 to 101.75)
Sandoz	98.68 (84.17 to 115.70)	87.60 (76.95 to 99.73)

Expressors: Geometric Accord/Astellas Ratio X 100: 115.78 (90% CI 107.04 to 125.22)
Expressors: Geometric Dr. Reddys/Astellas Ratio: 103.7 (90% CI 95.91 to 112.12)
Expressors: Geometric Mylan/Astellas Ratio X 100: 99.79 (90% CI 92.30 to 107.89)

Primary outcome: Compare Cmax of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients

Measure	Expressors n = 26	Non-expressors n = 27
Accord	21.72 (17.43 to 27.07)	15.07 (13.02 to 17.44)
Astellas	15.31 (12.29 to 19.07)	13.34 (11.53 to 15.44)
Dr. Reddys	15.94 (12.79 to 19.86)	13.58 (11.73 to 15.71)
Mylan	17.76 (14.26 to 22.13)	15.15 (13.09 to 17.53)
Panacea	16.67 (13.38 to 20.78)	13.23 (11.43 to 15.31)
Sandoz	14.40 (11.56 to 17.94)	12.75 (11.02 to 14.76)

Expressors: Geometric Accord/Astellas Ratio X 100: 141.91 (90% CI 125.73 to 160.16)
Expressors: Geometric Dr Reddys/Astellas Ratio X 100: 104.13 (90% CI 92.33 to 117.45)
Expressors: Geometric Mylan/Astellas Ratio X 100: 116.02 (90% CI 102.87 to 130.87)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Data was collected during the 6 week period enrolled in the pharmacokinetic study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Accord	0 of 53 (0%)	22 of 53 (41.5%)	0 of 53
Astellas	0 of 53 (0%)	14 of 53 (26.4%)	0 of 53
Dr. Reddys	0 of 53 (0%)	20 of 53 (37.7%)	0 of 53
Mylan	0 of 53 (0%)	22 of 53 (41.5%)	0 of 53
Panacea	0 of 53 (0%)	23 of 53 (43.4%)	0 of 53
Sandoz	0 of 53 (0%)	13 of 53 (24.5%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Rita R Alloway, PharmD principal investigator

University of Cincinnati

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prograf, Tacrolimus, Sandoz and Tacrolimus, Reddy Laboratory in people with Complication of Transplant, run by University of Cincinnati at 1 site in United States.

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 20 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 15 Oct 2024. 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 15 Oct 2024). 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?

Compare AUC 0-12hr of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients (time frame: Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.). The study lists 2 primary outcomes in all. 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 NCT02014103.

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 15 Oct 2024.