Kidney Transplant; ComplicationsPhase 4PTAAKNCT03841097
Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants
A Phase 4 study testing Extended Release Tacrolimus Tablets and Immediate Release Tacrolimus Capsule in people with Kidney Transplant; Complications, run by Roy D. Bloom, MD at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the pulse wave velocity and vascular compliance measurements at the beginning and the end of the study while the participants are taking either extended release tacrolimus tablets (known by brand name Envarsus XR®, and also referred to as LCPT in this study) given… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplant; Complications
- What is being tested?
- Extended Release Tacrolimus Tablets and Immediate Release Tacrolimus Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2019to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who self-report their race/ethnicity as Black-non-Hispanic only (which may include self-reported African ancestry as African-American, Afro-Caribbean or African)
- Subjects receiving a first or second deceased donor or living donor kidney transplant at the Hospital of the University of Pennsylvania
- Subjects whose body mass index (BMI) ≥19
- Subjects who are sero-positive for Hepatitis B or C positive may also be enrolled.
- Subjects whose concurrent immunosuppression at the time of transplant will be (generic or brand formulation) Mycophenolate mofetil (MMF, CellCept) or mycophenolic sodium (MPS, Myfortic®), either a standard prenisone taper or an early withdrawal protocol, and induction with rabbit-antithymocyte globulin (Thymoglobulin®).
Who cannot join
- Subjects who are greater than 75 years old
- Known hypersensitivity to Tacrolimus and hydrogenated castor oil
- Subjects who are not self-described as being of Black African descent and living in the United States
- Subjects who self-report their race/ethnicity as Black-Hispanic or Multiracial
- Subjects who are recipients of organ transplants other than kidney
- Subjects who are recipients of third time or more kidney transplants
Show all 18Show fewer
- Subjects who are HIV positive at the time of pre-transplant screening
- Subjects with recurrent focal segmental glomerulosclerosis (FSGS)
- Subjects with any severe medical condition (including infection or severe liver disease) requiring acute or chronic treatment that in the investigator's opinion would interfere with study participation
- Subjects with WBC ≤ 2000/mm3 or ANC ≤ 1500 mm3 with PLT ≤ 75,000/mm3 or HGB < 8 g/dL
- Subjects with mental or physical conditions or known non-adherence (defined as documentation in the patient chart of multiple missed visits and/or medication doses) which in the investigator's opinion would interfere with the objectives of the study
- Subjects who have been exposed to investigational therapy within 30 days prior to enrollment or five half-lives of the investigational product (whichever is greater).
- Subjects with severe diabetic gastroparesis or other severe GI disturbances that could interfere with Tacrolimus absorption
- Subjects who have underwent gastric bypass at any time pre transplant.
- Pregnant or nursing (lactating) women subjects, where pregnancy is defined as a state of female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml).
- Women subjects of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a double-barrier method of contraception, UNLESS they are
- Women whose career, lifestyle, or sexual orientation preclude intercourse with a male partner
- Women whose partners have been sterilized by vasectomy or other means
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase IV, Prospective, Randomized, Open-label, Comparative Analysis, Single-center Study of Pulse Wave Velocity Evaluation, Tacrolimus TTR and Co-efficient of Tacrolimus Variation of African American Kidney Recipients Receiving Standard of Care Immediate Release Tacrolimus Capsules or Extended Release Tacrolimus Tablets
The primary purpose of this study is to evaluate the pulse wave velocity and vascular compliance measurements at the beginning and the end of the study while the participants are taking either extended release tacrolimus tablets (known by brand name Envarsus XR®, and also referred to as LCPT in this study) given once-daily each morning after transplantation or immediate release tacrolimus capsules (also known by brand name Prograf® or abbreviation IR-TAC in this study) that are administered twice-daily 12 hours apart after kidney transplantation. Pulse wave velocity and vascular compliance measurements are two non-invasive tests that are used to evaluate how well the blood vessels adapt to each heartbeat. The secondary purpose is to look at the effectiveness and safety of LCPT given once-daily compared to IR-TAC given twice-daily 12 hours apart after kidney transplantation.
Read the detailed description
There are several medicines that are given to kidney transplant patients to prevent the body's immune system from rejecting (not accepting) the transplanted kidney. Frequently, more than one medicine is used at the same time to prevent rejection after kidney transplant. Some of the medicines currently used are IR-TAC, Mycophenolate mofetil (MMF), Mycophenolate sodium (MPS), and corticosteroids. IR-TAC is currently approved by the Food and Drug Administration (FDA) under the trade name of Prograf® or equivalent generic versions to prevent rejection in kidney transplant recipients. IR-TAC is taken twice daily (12 hours apart), and the dose is adjusted by the transplant provider to keep the level of tacrolimus in the blood from being too low or too high.
LCPT is a tablet containing the same active ingredient that is in IR-TAC but LCPT has been designed to release tacrolimus over a longer period of time so that it only has to be taken once a day in the morning. The dose of it is also adjusted by the transplant provider to keep the level of tacrolimus in the blood from being too low or too high. It has been approved by the FDA for prevention of rejection in kidney transplant recipients in combination with other medications to prevent rejection after kidney transplant.
In this study, the participants will be randomly assigned by chance (like flipping a coin) to receive either IR-TAC or LCPT from the time of transplant-on. Approximately half (30) of the study participants will be given IR-TAC and half will be given LCPT. Both the study participants and the transplant providers will know which medication that the participants are receiving. The participants will remain in the study for up to 12 months during which time they will be seen for monthly clinic visits, and complete labs per the standard of care.
Additionally, the study investigators will take an additional blood sample to further find out how the body absorbs and breaks down the medication tacrolimus. Participants will also undergo non-invasive pulse wave velocity and vascular compliance measurements within 3 days of post transplant, then 1 month and 12 months after transplant. Pulse wave velocity and vascular compliance measurements are two non-invasive tests that are used to evaluate how well the blood vessels adapt to each heartbeat. All participants will also be taking either Mycophenolate mofetil (MMF) or Mycophenolate sodium (MPS) and corticosteroids to prevent rejection. These procedures will help the investigators to look at the effectiveness and safety of LCPT compared to IR-TAC after kidney transplant.
- Conditions
- Kidney Transplant; Complications
- Being tested
- Extended Release Tacrolimus Tablets, Immediate Release Tacrolimus Capsule
- Keywords
- Renal, Transplant, Pulse wave velocity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Release Tacrolimus TabletsDrug
Also called LCPT, Envarsus XR®
The primary objective is to assess the change in pulse wave velocity (PWV) and vascular compliance measurements from baseline to 12-24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
Immediate Release Tacrolimus CapsuleDrug
Also called IR-TAC, Prograf®
The primary objective is to assess the change in pulse wave velocity (PWV) and vascular compliance measurements from baseline to 12-24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
| Study group | Role | What they receive |
|---|---|---|
| Extended Release Tacrolimus Tablets | Active comparator | Dosed once daily in the morning and started at a dose of 0.14 mg/kg/day by the first day after kidney transplant (post-operative day 1). This medication will be given with rabbit antithymocyte globulin (rATG) induction, oral mycophenolate mofetil (MMF) and oral steroids to help prevent rejection. These medications will be ordered per standard of care both inpatient and outpatient. Receives: Drug: Extended Release Tacrolimus Tablets |
| Immediate Release Tacrolimus Capsules | Active comparator | Dosed twice daily 12 hours apart and started at a dose of 0.1mg/kg/day by the first day after kidney transplant (post-operative day 1). This medication will be given with rabbit antithymocyte globulin (rATG) induction, oral mycophenolate mofetil (MMF) and oral steroids to help prevent rejection. These medications will be ordered per standard of care both inpatient and outpatient. Receives: Drug: Immediate Release Tacrolimus Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Change in Pulse Wave Velocity
To assess the change in PWV measurements (m/sec) from baseline to 12-24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
Measured: baseline and months 12-24 post transplant
Assess Change in Vascular Compliance measurements
To assess the change in vascular compliance using central blood pressure (mmHg) from baseline to 12-24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
Measured: baseline and months 12-24 post transplant
Assess Change in Vascular Compliance
To assess the change in vascular compliance using Augmentation Index (ratio) from baseline to 12 -24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
Measured: baseline and months 12-24 post transplant
Secondary outcomes (15)
Assess Change in Pulse Wave Velocity measurements
To assess the change in PWV measurements (m/sec) from baseline to 1 month after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
Measured: baseline and 1 month post transplant
Assess Change in Vascular Compliance measurements
To assess the change in vascular compliance using central blood pressure (mmHg) from baseline to 1 month after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
Augmentation Index (ratio) measurements from baseline to 1 month after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
Measured: baseline and 1 month post transplant
Assess Change in Vascular Compliance
To assess the change in vascular compliance using Augmentation Index (ratio) from baseline to 1 month after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
Augmentation Index (ratio) measurements from baseline to 1 month after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
Measured: baseline and 1 month post transplant
Compare Percent of Kidney Recipients with Tacrolimus Time in Therapeutic Range
To compare % of kidney recipient subjects with Tacrolimus time in therapeutic range (TTR) < 60% or < 75% by 12-24 months: (TTR will be defined as trough level between 7.5-12.5 ug/L between week 1 after transplant-month 1, 7.5-10.5ug/L between Months 2-3, 5.5-8.5 ug/L between months 4-12 after transplant, and 4.5-7.5ug/L 12 month onward) in patients on LCPT compared to those on IR-Tac.
Measured: 1 year
Compare the variability of Tacrolimus levels between LCPT and IR-Tac
To compare the variability of Tacrolimus levels between LCPT and IR-Tac using coefficient of variation (CV); high Tacrolimus CV will be defined > 40% during the first 12-24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
Measured: First 12-24 months
Compare steady-state mg/kg Tacrolimus dosing requirements
To compare steady-state mg/kg Tacrolimus dosing requirements to reach initial therapeutic troughs (defined as 8-12 ug/L) in kidney recipient subjects on LCPT compared to those on IR-Tac by CYP3A5*1 expressers vs. CYP3A5*1 non-expressers.
Measured: At baseline
Compare Tacrolimus-related medication adherence
To compare Tacrolimus-related medication adherence (measured by patient report of missed doses at transplant nephrology visits) in all kidney recipient subjects on LCPT compared to those on IR-Tac.
Measured: at months 1,2,3,6 and 12-24
Compare mean systolic and arterial blood pressure
To compare mean systolic and arterial blood pressure in all kidney recipient subjects on LCPT compared to those on IR-Tac.
Measured: at baseline and 12-24 months post-transplant
Compare anti-hypertensive medication use
To compare anti-hypertensive medication use in all kidney recipient subjects on LCPT compared to those on IR-Tac.
Measured: at baseline and 12-24 months post-transplant
Compare mean diastolic and arterial blood pressure
To compare mean diastolic and arterial blood pressure in all kidney recipient subjects on LCPT compared to those on IR-Tac.
Measured: at baseline and 12-24 months post-transplant
Compare estimated glomerular filtration rate (eGFR) measured by the Modification of Diet in Renal Disease (MDRD) formula
To compare estimated glomerular filtration rate (eGFR) via Modification of Diet in Renal Disease (MDRD) 4 calculation in all kidney recipient subjects on LCPT compared to those on IR-Tac.
Measured: At 6 months and 12-24 months post- transplant
Compare hemoglobin A1C values
To compare the occurrence of a new diagnosis pre-diabetes (as documented in the electronic health record) and hemoglobin A1C values in all non-diabetic kidney transplant subjects on LCPT compared to those on IR-Tac.
Measured: Post- transplant at months 3, 6, and 12-24
Compare the incidence of development of donor specific antibodies
To compare the incidence of development of donor specific antibodies (DSA) in all kidney recipient subjects on LCPT compared to those on IR-Tac.
Measured: At months 1, 3, 6 and 12-24 post- transplant
Compare the incidence of development of BK virus
To compare the incidence of development of BK virus (defined as BKV > 2.5 log copies/mL) in all kidney recipient subjects on LCPT compared to those on IR-Tac.
Measured: At months 1, 3, 6, and 12-24 post- transplant
Compare the incidence of serious adverse events
To compare the incidence of serious adverse events (SAEs) (including infections resulting in hospitalization, development of biopsy proven cellular and antibody mediated rejection by Banff criteria when biopsy performed for clinical indications, graft loss and patient death) in all kidney recipient subjects on LCPT compared to those on IR-Tac.
Measured: At months 6 and 12-24 post- transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start11 Nov 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roy D. Bloom, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Veloxis Pharmaceuticals
- Responsible party
- Sponsor-investigator, Roy D. Bloom, MD, University of Pennsylvania
- Investigators
- Roy D Bloom, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841097
- Sponsor's protocol ID
- 832046
- Acronym
- PTAAK
- Status last verified
- Jul 2026
- First submitted
- 10 Dec 2018
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Prospective, Randomized, Open-label, Comparative Analysis, Single-center Study of Pulse Wave Velocity Evaluation, Tacrolimus TTR and Co-efficient of Tacrolimus Variation of African American Kidney Recipients Receiving Standard of Care Immediate Release Tacrolimus Capsules or Extended Release Tacrolimus Tablets
- ClinicalTrials.gov ID
- NCT03841097
- Acronym / sponsor ID
- PTAAK / 832046
- Conditions
- Kidney Transplant; Complications
- Keywords
- Renal, Transplant, Pulse wave velocity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Roy D. Bloom, MDUniversity, hospital or other
- Collaborators
- Veloxis Pharmaceuticals
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the pulse wave velocity and vascular compliance measurements at the beginning and the end of the study while the participants are taking either extended release tacrolimus tablets (known by brand name Envarsus XR®, and also referred to as LCPT in this study) given once-daily each morning after transplantation or immediate release tacrolimus capsules (also known by brand name Prograf® or abbreviation IR-TAC in this study) that are administered twice-daily 12 hours apart after kidney transplantation. Pulse wave velocity and vascular compliance measurements are two non-invasive tests that are used to evaluate how well the blood vessels adapt to each heartbeat. The secondary purpose is to look at the effectiveness and safety of LCPT given once-daily compared to IR-TAC given twice-daily 12 hours apart after kidney transplantation.
Detailed description
There are several medicines that are given to kidney transplant patients to prevent the body's immune system from rejecting (not accepting) the transplanted kidney. Frequently, more than one medicine is used at the same time to prevent rejection after kidney transplant. Some of the medicines currently used are IR-TAC, Mycophenolate mofetil (MMF), Mycophenolate sodium (MPS), and corticosteroids. IR-TAC is currently approved by the Food and Drug Administration (FDA) under the trade name of Prograf® or equivalent generic versions to prevent rejection in kidney transplant recipients. IR-TAC is taken twice daily (12 hours apart), and the dose is adjusted by the transplant provider to keep the level of tacrolimus in the blood from being too low or too high.
LCPT is a tablet containing the same active ingredient that is in IR-TAC but LCPT has been designed to release tacrolimus over a longer period of time so that it only has to be taken once a day in the morning. The dose of it is also adjusted by the transplant provider to keep the level of tacrolimus in the blood from being too low or too high. It has been approved by the FDA for prevention of rejection in kidney transplant recipients in combination with other medications to prevent rejection after kidney transplant.
In this study, the participants will be randomly assigned by chance (like flipping a coin) to receive either IR-TAC or LCPT from the time of transplant-on. Approximately half (30) of the study participants will be given IR-TAC and half will be given LCPT. Both the study participants and the transplant providers will know which medication that the participants are receiving. The participants will remain in the study for up to 12 months during which time they will be seen for monthly clinic visits, and complete labs per the standard of care.
Additionally, the study investigators will take an additional blood sample to further find out how the body absorbs and breaks down the medication tacrolimus. Participants will also undergo non-invasive pulse wave velocity and vascular compliance measurements within 3 days of post transplant, then 1 month and 12 months after transplant. Pulse wave velocity and vascular compliance measurements are two non-invasive tests that are used to evaluate how well the blood vessels adapt to each heartbeat. All participants will also be taking either Mycophenolate mofetil (MMF) or Mycophenolate sodium (MPS) and corticosteroids to prevent rejection. These procedures will help the investigators to look at the effectiveness and safety of LCPT compared to IR-TAC after kidney transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Release Tacrolimus Tablets | Active comparator | Drug: Extended Release Tacrolimus TabletsDosed once daily in the morning and started at a dose of 0.14 mg/kg/day by the first day after kidney transplant (post-operative day 1). This medication will be given with rabbit antithymocyte globulin (rATG) induction, oral mycophenolate mofetil (MMF) and oral steroids to help prevent rejection. These medications will be ordered per standard of care both inpatient and outpatient. |
| Immediate Release Tacrolimus Capsules | Active comparator | Drug: Immediate Release Tacrolimus CapsuleDosed twice daily 12 hours apart and started at a dose of 0.1mg/kg/day by the first day after kidney transplant (post-operative day 1). This medication will be given with rabbit antithymocyte globulin (rATG) induction, oral mycophenolate mofetil (MMF) and oral steroids to help prevent rejection. These medications will be ordered per standard of care both inpatient and outpatient. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who self-report their race/ethnicity as Black-non-Hispanic only (which may include self-reported African ancestry as African-American, Afro-Caribbean or African)
- Subjects receiving a first or second deceased donor or living donor kidney transplant at the Hospital of the University of Pennsylvania
- Subjects whose body mass index (BMI) ≥19
- Subjects who are sero-positive for Hepatitis B or C positive may also be enrolled.
- Subjects whose concurrent immunosuppression at the time of transplant will be (generic or brand formulation) Mycophenolate mofetil (MMF, CellCept) or mycophenolic sodium (MPS, Myfortic®), either a standard prenisone taper or an early withdrawal protocol, and induction with rabbit-antithymocyte globulin (Thymoglobulin®).
Key exclusion criteria (18 listed)
- Subjects who are greater than 75 years old
- Known hypersensitivity to Tacrolimus and hydrogenated castor oil
- Subjects who are not self-described as being of Black African descent and living in the United States
- Subjects who self-report their race/ethnicity as Black-Hispanic or Multiracial
- Subjects who are recipients of organ transplants other than kidney
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 |
|---|---|---|
| Extended Release Tacrolimus TabletsAlso: LCPT, Envarsus XR®The primary objective is to assess the change in pulse wave velocity (PWV) and vascular compliance measurements from baseline to 12-24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac. | Drug | Extended Release Tacrolimus Tablets |
| Immediate Release Tacrolimus CapsuleAlso: IR-TAC, Prograf®The primary objective is to assess the change in pulse wave velocity (PWV) and vascular compliance measurements from baseline to 12-24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac. | Drug | Immediate Release Tacrolimus Capsules |
Primary outcome
Assess Change in Pulse Wave Velocity
Time frame: baseline and months 12-24 post transplant
To assess the change in PWV measurements (m/sec) from baseline to 12-24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
Assess Change in Vascular Compliance measurements
Time frame: baseline and months 12-24 post transplant
To assess the change in vascular compliance using central blood pressure (mmHg) from baseline to 12-24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
Assess Change in Vascular Compliance
Time frame: baseline and months 12-24 post transplant
To assess the change in vascular compliance using Augmentation Index (ratio) from baseline to 12 -24 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
15 secondary outcomes
Assess Change in Pulse Wave Velocity measurements
Time frame: baseline and 1 month post transplant
Assess Change in Vascular Compliance measurements
Time frame: baseline and 1 month post transplant
Assess Change in Vascular Compliance
Time frame: baseline and 1 month post transplant
Compare Percent of Kidney Recipients with Tacrolimus Time in Therapeutic Range
Time frame: 1 year
Compare the variability of Tacrolimus levels between LCPT and IR-Tac
Time frame: First 12-24 months
Compare steady-state mg/kg Tacrolimus dosing requirements
Time frame: At baseline
Compare Tacrolimus-related medication adherence
Time frame: at months 1,2,3,6 and 12-24
Compare mean systolic and arterial blood pressure
Time frame: at baseline and 12-24 months post-transplant
Compare anti-hypertensive medication use
Time frame: at baseline and 12-24 months post-transplant
Compare mean diastolic and arterial blood pressure
Time frame: at baseline and 12-24 months post-transplant
Compare estimated glomerular filtration rate (eGFR) measured by the Modification of Diet in Renal Disease (MDRD) formula
Time frame: At 6 months and 12-24 months post- transplant
Compare hemoglobin A1C values
Time frame: Post- transplant at months 3, 6, and 12-24
Compare the incidence of development of donor specific antibodies
Time frame: At months 1, 3, 6 and 12-24 post- transplant
Compare the incidence of development of BK virus
Time frame: At months 1, 3, 6, and 12-24 post- transplant
Compare the incidence of serious adverse events
Time frame: At months 6 and 12-24 post- transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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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.
Roy D Bloom, MD principal investigator
University of Pennsylvania
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 Extended Release Tacrolimus Tablets and Immediate Release Tacrolimus Capsule in people with Kidney Transplant; Complications, run by Roy D. Bloom, MD 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 18 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Assess Change in Pulse Wave Velocity (time frame: baseline and months 12-24 post transplant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2026.