Kidney Transplant RejectionPhase 4NCT02974686
Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation
A Phase 4 study testing Everolimus and Mycophenolic Acid in people with Kidney Transplant Rejection and Gastrointestinal Disorder, Functional, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Patients who receive renal transplantation at Barnes Jewish Hospital (BJH) are placed on triple maintenance immunosuppression, which means that patients take 3 types of immunosuppression drugs to suppress their immune system including tacrolimus, mycophenolate (MPA), and prednisone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection, Gastrointestinal Disorder, Functional
- What is being tested?
- Everolimus and Mycophenolic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Sep 2019
- 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
- Kidney transplant recipients at Washington University/Barnes-Jewish Hospital
- Experiencing GI toxicity from MPA as determined by the treating physician within 12 months post-renal transplant
- On standard immunosuppression with tacrolimus and prednisone
Who cannot join
- Dual organ or kidney after another solid organ transplant
- Presence of a preexisting significant GI condition that does not have a presumed causal relationship with MPA
- Evidence of any GI disorder induced by an infection, underlying medical condition, or concomitant medication other than MPA
- Estimated glomerular filtration rate (eGFR) <40 ml/min at time of possible conversion
- Proteinuria >1 gram/day at time of possible conversion
- Profound bone marrow suppression at the time of possible conversion as defined as:
Show all 12Show fewer
- Hemoglobin <10 g/dL
- White blood cell (WBC) < 3 K/cumm
- Platelets <100 K/cumm
- Wound healing issues at time of possible conversion (eg, wound dehiscence, wound infection, incisional hernia, lymphocele, seroma)
- Elevated total cholesterol (>350 mg/dL) and/or triglycerides (>500 ng/dL) at time of possible conversion
- Hypersensitivity to everolimus, sirolimus, or other rapamycin derivatives
Trial locations and contacts
1 site in 1 country.
About this study
Patients who receive renal transplantation at Barnes Jewish Hospital (BJH) are placed on triple maintenance immunosuppression, which means that patients take 3 types of immunosuppression drugs to suppress their immune system including tacrolimus, mycophenolate (MPA), and prednisone. However, due to the effects of MPA on the gastrointestinal tract, patients often complain of GI adverse effects. Current practice is to either dose-reduce MPA or convert the patient to an alternative agent, typically Azathioprine. Both of these strategies have limitations, largely due to concerns related to efficacy. Everolimus (EVR) has demonstrated similar efficacy to MPA in renal transplantation and may offer a benefit related to GI adverse effects, so the investigators will convert patients to EVR in this study. Patients who are within their first year post-transplant will be converted to EVR upon enrollment in the study, and serial measurements ,or a series of measurements looking for an increase or decrease over time, of GI adverse effects will be conducted over 1 year post-enrollment.
- Being tested
- Everolimus, Mycophenolic Acid
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Zortress
Mycophenolic AcidDrug
Also called Cellcept, Myfortic
| Study group | Role | What they receive |
|---|---|---|
| Interventional (EVR) | Active comparator | Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus Receives: Drug: Everolimus |
| Prior Agent (MPA) | Active comparator | Patient will have baseline data collected while on MPA for comparison with EVR Receives: Drug: Mycophenolic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Symptom Rating Scale
Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
Measured: 3 months
Secondary outcomes (2)
Gastrointestinal Symptom Rating Scale
Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
Measured: 1, 6, and 12 months
Biopsy Proven Acute Rejection
Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
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 posted28 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2019
- Study completionSep 2019
Why it stopped: low recruitment
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 Kidney Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974686
- Sponsor's protocol ID
- 201603167
- Other IDs
- CRAD001AUS209T
- Status last verified
- Aug 2020
- First submitted
- 3 Nov 2016
- Last updated
- 10 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation
- ClinicalTrials.gov ID
- NCT02974686
- Acronym / sponsor ID
- 201603167
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Nov 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 28 Nov 2016 (estimated)
- Results
- Posted 10 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who receive renal transplantation at Barnes Jewish Hospital (BJH) are placed on triple maintenance immunosuppression, which means that patients take 3 types of immunosuppression drugs to suppress their immune system including tacrolimus, mycophenolate (MPA), and prednisone. However, due to the effects of MPA on the gastrointestinal tract, patients often complain of GI adverse effects. Current practice is to either dose-reduce MPA or convert the patient to an alternative agent, typically Azathioprine. Both of these strategies have limitations, largely due to concerns related to efficacy. Everolimus (EVR) has demonstrated similar efficacy to MPA in renal transplantation and may offer a benefit related to GI adverse effects, so the investigators will convert patients to EVR in this study. Patients who are within their first year post-transplant will be converted to EVR upon enrollment in the study, and serial measurements ,or a series of measurements looking for an increase or decrease over time, of GI adverse effects will be conducted over 1 year post-enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional (EVR) | Active comparator | Drug: EverolimusPatients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus |
| Prior Agent (MPA) | Active comparator | Drug: Mycophenolic AcidPatient will have baseline data collected while on MPA for comparison with EVR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Kidney transplant recipients at Washington University/Barnes-Jewish Hospital
- Experiencing GI toxicity from MPA as determined by the treating physician within 12 months post-renal transplant
- On standard immunosuppression with tacrolimus and prednisone
Key exclusion criteria (12 listed)
- Dual organ or kidney after another solid organ transplant
- Presence of a preexisting significant GI condition that does not have a presumed causal relationship with MPA
- Evidence of any GI disorder induced by an infection, underlying medical condition, or concomitant medication other than MPA
- Estimated glomerular filtration rate (eGFR) <40 ml/min at time of possible conversion
- Proteinuria >1 gram/day at time of possible conversion
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 |
|---|---|---|
| EverolimusAlso: Zortress | Drug | Interventional (EVR) |
| Mycophenolic AcidAlso: Cellcept, Myfortic | Drug | Prior Agent (MPA) |
Primary outcome
Gastrointestinal Symptom Rating Scale
Time frame: 3 months
Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
2 secondary outcomes
Gastrointestinal Symptom Rating Scale
Time frame: 1, 6, and 12 months
Biopsy Proven Acute Rejection
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 10 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Everolimus and Mycophenolic Acid in people with Kidney Transplant Rejection and Gastrointestinal Disorder, Functional, run by Washington University School of Medicine 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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 10 Aug 2020. 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 10 Aug 2020). 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?
Gastrointestinal Symptom Rating Scale (time frame: 3 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 10 Aug 2020.