End Stage Renal Disease (ESRD)Phase 4NCT00374803
Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
A Phase 4 study testing Mycophenolic Acid (Myfortic) in people with End Stage Renal Disease (ESRD), run by University of Cincinnati at 2 sites in United States.
Trial summary
To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Disease (ESRD)
- What is being tested?
- Mycophenolic Acid (Myfortic)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to Jan 2008
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between 18 and 75 years of age.
- Patients who are primary or repeat cadaveric, living unrelated or non-HLA identical living related donor renal transplant recipients.
Who cannot join
- Patient previously received or is receiving an organ transplant other than kidney.
- Primary or re-transplant from human leukocyte antigen (HLA)-identical living donor.
- Recipient or donor is known to be seropositive for hepatitis C virus (HCV), hepatitis B virus (HBV), or human immunodeficiency virus (HIV).
- Uncontrolled concomitant infection or other unstable medical condition.
- Patients that received an investigational drug in the 30 days prior to transplant.
- Known hypersensitivity to tacrolimus, mycophenolate mofetil (MMF), enteric-coated mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.
Show all 9Show fewer
- Receiving chronic steroid therapy at the time of transplant.
- History of malignancy in last 5 years.
- Pregnant or lactating.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Christ Hospital
Cincinnati, Ohio, 45267
University of Cincinnati
Cincinnati, Ohio, 45267
About this study
Official title: A 12-month, Prospective, Randomized, Single Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.
Read the detailed description
Evaluate the safety and efficacy of Myfortic in combination with tacrolimus and anti-thymocyte globulin in an early corticosteroid withdrawal protocol. Secondary objective is to determine the pharmacokinetic-pharmacodynamic profile of Myfortic in a corticosteroid withdrawal protocol.
- Conditions
- End Stage Renal Disease (ESRD)
- Being tested
- Mycophenolic Acid (Myfortic)
- Keywords
- Kidney, Transplant, Corticosteroid, Myfortic
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolic Acid (Myfortic)Drug
Also called mycophenolic acid enteric coated
- Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
- Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolic Acid (Myfortic) Preload | Experimental | Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter Receives: Drug: Mycophenolic Acid (Myfortic) |
| Mycophenolic Acid (Myfortic) Standard | Active comparator | Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day). Receives: Drug: Mycophenolic Acid (Myfortic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of All Biopsy Proven Acute Rejection.
Treatment efficacy, defined as the incidence of all biopsy proven acute rejection. Biopsy was proven with tissue samples collected on patients with elevated serum creatinine
Measured: 12 months
Secondary outcomes (4)
Patient and Allograft Survival 12 Months
Patient and allograft survival at 12 months post-transplant. Allograft survival is different from rejection. An allograft can have rejection, but the allograft can still have survival. If an allograft fails and is no longer functioning this would be considered allograft failure and non-survival.
Measured: 12 months
Renal Function at 12 Months
Renal function measured by serum creatinine (SCr) at 12 months post-transplant
Measured: 12 months
Incidence of Post Transplant Infections
Incidence of post transplant infections that resulted in hospitalization
Measured: 12 months
GI Toxicities
Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startApr 2006
- Primary completionJan 2008
- Study completionJan 2008
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 End Stage Renal Disease (ESRD)Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Rita Alloway, University of Cincinnati
- Investigators
- Rita Alloway, PharmD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374803
- Sponsor's protocol ID
- MyforticINVINT
- Status last verified
- Mar 2016
- First submitted
- 8 Sep 2006
- Last updated
- 28 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month, Prospective, Randomized, Single Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
- ClinicalTrials.gov ID
- NCT00374803
- Acronym / sponsor ID
- MyforticINVINT
- Conditions
- End Stage Renal Disease (ESRD)
- Keywords
- Kidney, Transplant, Corticosteroid, Myfortic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Apr 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 11 Sep 2006 (estimated)
- Results
- Posted 8 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.
Detailed description
Evaluate the safety and efficacy of Myfortic in combination with tacrolimus and anti-thymocyte globulin in an early corticosteroid withdrawal protocol. Secondary objective is to determine the pharmacokinetic-pharmacodynamic profile of Myfortic in a corticosteroid withdrawal protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mycophenolic Acid (Myfortic) Preload | Experimental | Drug: Mycophenolic Acid (Myfortic)Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter |
| Mycophenolic Acid (Myfortic) Standard | Active comparator | Drug: Mycophenolic Acid (Myfortic)Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females between 18 and 75 years of age.
- Patients who are primary or repeat cadaveric, living unrelated or non-HLA identical living related donor renal transplant recipients.
Key exclusion criteria (9 listed)
- Patient previously received or is receiving an organ transplant other than kidney.
- Primary or re-transplant from human leukocyte antigen (HLA)-identical living donor.
- Recipient or donor is known to be seropositive for hepatitis C virus (HCV), hepatitis B virus (HBV), or human immunodeficiency virus (HIV).
- Uncontrolled concomitant infection or other unstable medical condition.
- Patients that received an investigational drug in the 30 days prior to transplant.
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 |
|---|---|---|
| Mycophenolic Acid (Myfortic)Also: mycophenolic acid enteric coated* Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter * Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day). | Drug | Mycophenolic Acid (Myfortic) Preload, Mycophenolic Acid (Myfortic) Standard |
Primary outcome
Incidence of All Biopsy Proven Acute Rejection.
Time frame: 12 months
Treatment efficacy, defined as the incidence of all biopsy proven acute rejection. Biopsy was proven with tissue samples collected on patients with elevated serum creatinine
4 secondary outcomes
Patient and Allograft Survival 12 Months
Time frame: 12 months
Renal Function at 12 Months
Time frame: 12 months
Incidence of Post Transplant Infections
Time frame: 12 months
GI Toxicities
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- 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 Alloway, PharmD principal investigator
University of Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mycophenolic Acid (Myfortic) in people with End Stage Renal Disease (ESRD), run by University of Cincinnati at 2 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 2 inclusion and 9 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 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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 8 May 2012). 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?
Incidence of All Biopsy Proven Acute Rejection. (time frame: 12 months). 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 28 Apr 2016.