Renal FailurePhase 2NCT01666951

Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant

A Phase 2 study testing LCP-Tacro tablets and Prograf in people with Renal Failure, run by Veloxis Pharmaceuticals at 13 sites 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 purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Renal Failure
What is being tested?: LCP-Tacro tablets and Prograf
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 13 sitesUnited States
Study dates: Nov 2012to May 2013
Phase: Phase 2
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Give written consent
Male and female subjects between the ages of 18 and 70 years, inclusive
Must be receiving primary or secondary renal allograft from a deceased donor or non- HLA identical living donor
WOCBP must have a negative pregnancy test
Must have negative cross-match test and be ABO-compatible
Must be able to swallow tablets and capsules

Who cannot join

Recipients of any previous nonrenal or concurrent transplant
Have panel reactive antibody >50%
Any condition that may affect study drug absorption BMI <18 kg/m2 or > 45 kg/m2
History of alcohol abuse with less than 6 months of sobriety
History of recreational drug abuse with less than 6 months of documented abstinence
Screening 12-lead ECG demonstrating CS abnormalities (including QTc prolongation)

Show all 22Show fewer

WOCBP and are either pregnant, lactating, planning to become pregnant or with a positive serum or urine pregnancy test
Subjects (male or female) with reproductive potential who are unwilling/unable to use a double-barrier method
Oral temperature (prior to study drug dosing) of 38.0ºC or higher
CS active infections (eg, those requiring hospitalization, or as judged by the Investigator)
Known hereditary immunodeficiency
Malignancies or with a history of malignancies (within the last 5 years) with the exception of local, noninvasive, fully excised cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ
Expect to receive within 2 months after randomization, or have received within 3 months prior to screening, any of the following: sirolimus, everolimus, belatacept, or cyclophosphamide
Any psychiatric or medical condition that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Clinically symptomatic CHF or documented EJF of less than 45%
Significant COPD, pulmonary restrictive disease or significant pulmonary hypertension
Enrolled in another investigational drug or device study, or who are less than 30 days since discontinuing
Laboratory variables that are abnormal (outside laboratory reference range) and CS
Positive results of any of the following serological tests: human immunodeficiency virus (HIV)-1 antibody, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and anti-hepatitis C virus (HCV) antibody (HCV Ab)
Subjects who have had primary focal segmental glomerulosclerosis
Donor parameters must not include any of the following known conditions:
Donor with positive serological test result for HIV-1, HBV or HCV Donor with history of malignant disease (current or historical) Cold ischemia time >30 hours Non-heart-beating donor

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Clinical Investigative Site 000009
Ann Arbor, Michigan, 48109
Clinical Investigative Site 00004
Aurora, Colorado, 80045
Clinical Investigative Site 000011
Buffalo, New York, 14215
Clinical Investigative Site 00001
Charlottesville, Virginia, 22903
Clinical Investigative Site 00008
Cleveland, Ohio, 44095
Clinical Investigative Site 000013
Dallas, Texas, 75246
Clinical Investigative Site 000005
Lexington, Kentucky, 40536-0293
Clinical Investigative Site 000010
Livingston, New Jersey, 07039
Clinical Investigative Site 00006
New York, New York, 10016
Clinical Investigative Site 00003
Philadelphia, Pennsylvania, 19104
Clinical Investigative Site 000015
San Diego, California, 92123
Clinical Investigative Site 000012
San Francisco, California, 94115
Clinical Investigative Site 000002
Tampa, Florida, 33606

Other trials in United States

About this study

Official title: Ph 2 Double-blind, Double-dummy, Multicenter, Prospective, Rand Study of PK of LCP-Tacro™ Tablets Once Daily, Compared to Prograf® Caps, Twice Daily, for Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients

The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.

Read the detailed description

This is a 2-arm , parallel group, prospective, double-blind, double-dummy, multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily in comparison to Prograf capsules twice-daily after kidney transplantation.

Conditions: Renal Failure
Being tested: LCP-Tacro tablets, Prograf
Medical subject headings: Renal Insufficiency

What participants receive

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

LCP-Tacro tabletsDrug
Also called Prograf
Tacrolimus
PrografDrug
Also called Prograf Capsules twice daily
Tacrolimus

Study groups in NCT01666951
Study group	Role	What they receive
LCP-Tacro	Experimental	LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK) Receives: Drug: LCP-Tacro tablets
Prograf	Active comparator	Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL) Receives: Drug: Prograf

What is being measured

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

Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.
Measured: 1 days
Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.
Measured: 14 days
Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.
Measured: 28 days
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.
Measured: 1 days
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.
Measured: 14 days
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.
Measured: 28 days
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.
Measured: 1 days
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.
Measured: 14 days
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.
Measured: 28 days
Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.
Measured: 14 days
Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.
Measured: 28 days

Timeline

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

Nov 2012May 2013

First posted16 Aug 2012 (estimated)
Study startNov 2012
Primary completionMar 2013
Study completionMay 2013

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 Renal FailureStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01666951
Sponsor's protocol ID: LCP-Tacro 2019
Status last verified: Jun 2015
First submitted: 14 Aug 2012
Last updated: 7 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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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Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ph 2 Double-blind, Double-dummy, Multicenter, Prospective, Rand Study of PK of LCP-Tacro™ Tablets Once Daily, Compared to Prograf® Caps, Twice Daily, for Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT01666951
Acronym / sponsor ID: LCP-Tacro 2019
Conditions: Renal Failure
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Veloxis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Mar 2013 (actual)
Study completion: May 2013 (actual)
First posted: 16 Aug 2012 (estimated)
Results: Posted 7 Jul 2015

Clinical summary

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

The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
LCP-Tacro	Experimental	Drug: LCP-Tacro tabletsLCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
Prograf	Active comparator	Drug: PrografPrograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Give written consent
Male and female subjects between the ages of 18 and 70 years, inclusive
Must be receiving primary or secondary renal allograft from a deceased donor or non- HLA identical living donor
WOCBP must have a negative pregnancy test
Must have negative cross-match test and be ABO-compatible

Key exclusion criteria (22 listed)

Recipients of any previous nonrenal or concurrent transplant
Have panel reactive antibody >50%
Any condition that may affect study drug absorption BMI <18 kg/m2 or > 45 kg/m2
History of alcohol abuse with less than 6 months of sobriety
History of recreational drug abuse with less than 6 months of documented abstinence

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
LCP-Tacro tabletsAlso: PrografTacrolimus	Drug	LCP-Tacro
PrografAlso: Prograf Capsules twice dailyTacrolimus	Drug	Prograf

Primary outcome

Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Time frame: 1 days
The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.
Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Time frame: 14 days
The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.
Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Time frame: 28 days
The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Time frame: 1 days
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Time frame: 14 days
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Time frame: 28 days
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Time frame: 1 days
The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Time frame: 14 days
The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Time frame: 28 days
The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.
Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Time frame: 14 days
The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.
Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Time frame: 28 days
The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.

Results and safety

Results posted to the registry on 7 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LCP-Tacro	18	17
Prograf	18	17

Primary outcome: Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation

Time frame: 1 days. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	LCP-Tacro n = 14	Prograf n = 12
Value	382.72 (233.84)	147.82 (85.31)

Population analysed: The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.

Primary outcome: Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation

Time frame: 14 days. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	LCP-Tacro n = 14	Prograf n = 12
Value	371.43 (133.85)	244.63 (66.92)

Population analysed: The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.

Primary outcome: Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation

Time frame: 28 days. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	LCP-Tacro n = 14	Prograf n = 12
Value	357.39 (146.64)	205.79 (36.25)

Population analysed: The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.

Primary outcome: Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation

Time frame: 1 days. Mean (Standard Deviation). Unit: ng/mL

Measure	LCP-Tacro n = 14	Prograf n = 12
Cmax	32.68 (20.51)	12.97 (7.08)
C24	13.32 (8.89)	5.72 (5.28)

Population analysed: The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.

Adverse events

Time frame: Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LCP-Tacro	5 of 17 (29.4%)	17 of 17 (100%)	Not reported
Prograf	5 of 17 (29.4%)	17 of 17 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

William Polvino, MD study director

Veloxis Pharmaceuticals

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LCP-Tacro tablets and Prograf in people with Renal Failure, run by Veloxis Pharmaceuticals at 13 sites 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 6 inclusion and 22 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 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 7 Jul 2015). 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?

Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation (time frame: 1 days). The study lists 11 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 NCT01666951.

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 7 Jul 2015.