Renal TransplantNCT01612299
Effects of Zortress® + Tacrolimus vs. Standard Immunosuppression on Progression of Coronary Artery Calcifications and Bone Disease in de Novo Renal Transplant Recipients
A study testing Zortress® /Everolimus in people with Renal Transplant, run by University of Kentucky at 1 site in United States.
Trial summary
Primary objectives: A. To evaluate the effect of Zortress® versus standard immunosuppression therapy on progression of CAC as evidenced by changes in Agatston scores from baseline and at 6, and 12 months in renal transplantation patients. B. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Transplant
- What is being tested?
- Zortress® /Everolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- De novo renal transplant recipients (from deceased or living donors) between 18-70 years of age
- Willingness to participate in the study and comply with study requirements as evidenced by signed IRB-approved informed consent
- Enrollment Exclusion Criteria:
- Previous solid organ transplant
- Known hypersensitivity to any of the study drugs, or their class, or to any of their excipients
- Recipients of an investigational drug within 30 days before transplant
Show all 17Show fewer
- Any abnormal physical or laboratory findings of clinical significance which would interfere with conduct of the study
- Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, or unwilling to use medically approved means of contraception
- Randomization Exclusion Criteria:
- Platelet count <75,000/mm
- White blood cell count of < 2,000/mm³
- Hypercholesterolemia (>400 mg/dL) or hypertriglyceridemia (>500 mg/dL) despite lipid-lowering therapy
- Presence of any clinically significant infection requiring IV antibiotics
- Positive serum HCG (women of childbearing potential)
- Spot urine protein to creatinine ratio (UPr/Cr ) ≥ 0.5
- Any biopsy-confirmed acute rejection since transplant
- Baseline CAC score < 100 at baseline reading
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Primary objectives: A. To evaluate the effect of Zortress® versus standard immunosuppression therapy on progression of CAC as evidenced by changes in Agatston scores from baseline and at 6, and 12 months in renal transplantation patients. B. To investigate progression of CAC in patients undergoing renal transplantation within the study period.
Secondary objectives:
- To evaluate in renal transplantation the effect of Zortress® versus standard immunosuppression therapy on bone mass as evidenced by changes in quantitative computed tomography (QCT) and dual energy X-ray absorptiometry (DXA).
- To evaluate in renal transplantation the effect of Zortress® versus standard immunosuppression therapy on activity of bone forming and resorbing cells as evidenced by changes in bone histology.
- To evaluate in renal transplantation the effect of Zortress® versus standard immunosuppression therapy on biochemical parameters of bone turnover as evidenced by changes in serum Parathyroid Hormone (PTH), Bone-Specific Alkaline Phosphatase (BSAP), Tartrate-Resistant Acid Phosphatase (TRAP), Sclerostin, Receptor Activator of Nuclear factor Kappa B Ligand (RANKL), Osteoprotegerin (OPG), , serum CTX (C-terminal telopeptide of type 1 collagen), and urinary NTX (N-terminal cross link telopeptide).
- To evaluate in renal transplantation the effect of Zortress® versus standard immunosuppression therapy on cardiovascular events, graft rejection and patient survival.
- Conditions
- Renal Transplant
- Being tested
- Zortress® /Everolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zortress® /EverolimusDrug
Standard immunosuppression: THY 1-1.5 mg/kg/d qd for a total of 6 mg/kg •TAC trough targets 0-3 mo 8-12 ng/ml 4-6 mo 6-10 ng/ml >6 mo 5-8 ng/ml•Myfortic® or CEL 360mg or 500mg po BID, and receiving THY then Myfortic® or CEL 720 mg or 1000mg PO BID once THY induction completed• COR 500mg MET IV pre-op,125mg MET IV q24h x 2 doses (Post-Op Days 1 \&2) 20mg Pred PO daily x 2 wks 15mg Pred PO daily x 2 wks 10mg Pred PO daily x 4 wks 5mg Pred PO daily x 4 wks 5 mg Pred PO every other day through mon 12.
Experimental: TAC + Zortress® + COR In this arm patients will stop Myfortic®/CEL and start Zortress® at a dose of 1 mg PO BID with a target level of 3-8 ng/ml.At Zortress® level of at least 3 ng/ml TAC will be dosed to a target range as follows Randomization through mo 3 post-transplant 7-10 ng/ml 4-6 mo post transplant 5-8 ng/ml >6 mo post transplant 4-7 ng/ml.
| Study group | Role | What they receive |
|---|---|---|
| Standard Immunosuppression | Active comparator | Tacrolimus + Myfortic®/Cellcept + Corticosteroids Receives: Drug: Zortress® /Everolimus |
| Zortress® | Experimental | Tacrolimus + Zortress® + Corticosteroids Receives: Drug: Zortress® /Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression of Coronary Artery Calcification
The primary outcome of this study is the proportion of pts in the treatment group who experience a 1yr increase of ≥2.5 for the square-root transformed volume indicating CAC progression. Student's Fisher's Exact T-tests will be used to determine progression of CAC score between control \& treatment groups. Secondary objectives 1-3 examine 1yr changes in several measurement outcome variables. Fisher's exact tests \& confidence intervals for the difference in proportions will be used to compare the two groups in terms of cardiovascular events, graft rejection, \& pt survival.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Funding was withdrawn for this study by the sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hartmut Malluche, MD, University of Kentucky
- Investigators
- Hartmut Malluche, MD, Principal investigator, University of KentuckyRoberto Gedaly, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612299
- Sponsor's protocol ID
- 3048108907
- Status last verified
- Aug 2017
- First submitted
- 30 May 2012
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Zortress® + Tacrolimus vs. Standard Immunosuppression on Progression of Coronary Artery Calcifications and Bone Disease in de Novo Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT01612299
- Acronym / sponsor ID
- 3048108907
- Conditions
- Renal Transplant
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was withdrawn for this study by the sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Jun 2012 (estimated)
- 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.
Primary objectives: A. To evaluate the effect of Zortress® versus standard immunosuppression therapy on progression of CAC as evidenced by changes in Agatston scores from baseline and at 6, and 12 months in renal transplantation patients. B. To investigate progression of CAC in patients undergoing renal transplantation within the study period.
Secondary objectives:
- To evaluate in renal transplantation the effect of Zortress® versus standard immunosuppression therapy on bone mass as evidenced by changes in quantitative computed tomography (QCT) and dual energy X-ray absorptiometry (DXA).
- To evaluate in renal transplantation the effect of Zortress® versus standard immunosuppression therapy on activity of bone forming and resorbing cells as evidenced by changes in bone histology.
- To evaluate in renal transplantation the effect of Zortress® versus standard immunosuppression therapy on biochemical parameters of bone turnover as evidenced by changes in serum Parathyroid Hormone (PTH), Bone-Specific Alkaline Phosphatase (BSAP), Tartrate-Resistant Acid Phosphatase (TRAP), Sclerostin, Receptor Activator of Nuclear factor Kappa B Ligand (RANKL), Osteoprotegerin (OPG), , serum CTX (C-terminal telopeptide of type 1 collagen), and urinary NTX (N-terminal cross link telopeptide).
- To evaluate in renal transplantation the effect of Zortress® versus standard immunosuppression therapy on cardiovascular events, graft rejection and patient survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Immunosuppression | Active comparator | Drug: Zortress® /EverolimusTacrolimus + Myfortic®/Cellcept + Corticosteroids |
| Zortress® | Experimental | Drug: Zortress® /EverolimusTacrolimus + Zortress® + Corticosteroids |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- De novo renal transplant recipients (from deceased or living donors) between 18-70 years of age
- Willingness to participate in the study and comply with study requirements as evidenced by signed IRB-approved informed consent
- Previous solid organ transplant
- Known hypersensitivity to any of the study drugs, or their class, or to any of their excipients
- Recipients of an investigational drug within 30 days before transplant
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Zortress® /EverolimusStandard immunosuppression: THY 1-1.5 mg/kg/d qd for a total of 6 mg/kg •TAC trough targets 0-3 mo 8-12 ng/ml 4-6 mo 6-10 ng/ml >6 mo 5-8 ng/ml•Myfortic® or CEL 360mg or 500mg po BID, and receiving THY then Myfortic® or CEL 720 mg or 1000mg PO BID once THY induction completed• COR 500mg MET IV pre-op,125mg MET IV q24h x 2 doses (Post-Op Days 1 \&2) 20mg Pred PO daily x 2 wks 15mg Pred PO daily x 2 wks 10mg Pred PO daily x 4 wks 5mg Pred PO daily x 4 wks 5 mg Pred PO every other day through mon 12. Experimental: TAC + Zortress® + COR In this arm patients will stop Myfortic®/CEL and start Zortress® at a dose of 1 mg PO BID with a target level of 3-8 ng/ml.At Zortress® level of at least 3 ng/ml TAC will be dosed to a target range as follows Randomization through mo 3 post-transplant 7-10 ng/ml 4-6 mo post transplant 5-8 ng/ml >6 mo post transplant 4-7 ng/ml. | Drug | Standard Immunosuppression, Zortress® |
Primary outcome
progression of Coronary Artery Calcification
Time frame: 1 year
The primary outcome of this study is the proportion of pts in the treatment group who experience a 1yr increase of ≥2.5 for the square-root transformed volume indicating CAC progression. Student's Fisher's Exact T-tests will be used to determine progression of CAC score between control \& treatment groups. Secondary objectives 1-3 examine 1yr changes in several measurement outcome variables. Fisher's exact tests \& confidence intervals for the difference in proportions will be used to compare the two groups in terms of cardiovascular events, graft rejection, \& pt survival.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
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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.
Hartmut Malluche, MD principal investigator
University of Kentucky
Roberto Gedaly, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zortress® /Everolimus in people with Renal Transplant, run by University of Kentucky 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 17 inclusion and 0 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: withdrawn, as of the sponsor's last update on 7 Aug 2017. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
progression of Coronary Artery Calcification (time frame: 1 year). 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 7 Aug 2017.