Gastrointestinal Disorder, Functional, Kidney Transplant Rejection
Conditions
Brief 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. 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.
Interventions
DRUGEverolimus
DRUGMycophenolic Acid
Sponsors
Novartis Pharmaceuticals
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Kidney transplant recipients at Washington University/Barnes-Jewish Hospital 2. Experiencing GI toxicity from MPA as determined by the treating physician within 12 months post-renal transplant 3. On standard immunosuppression with tacrolimus and prednisone
Exclusion criteria
1. Dual organ or kidney after another solid organ transplant 2. Presence of a preexisting significant GI condition that does not have a presumed causal relationship with MPA 3. Evidence of any GI disorder induced by an infection, underlying medical condition, or concomitant medication other than MPA 4. Estimated glomerular filtration rate (eGFR) \<40 ml/min at time of possible conversion 5. Proteinuria \>1 gram/day at time of possible conversion 6. Profound bone marrow suppression at the time of possible conversion as defined as: * Hemoglobin \<10 g/dL * White blood cell (WBC) \< 3 K/cumm * Platelets \<100 K/cumm 7. Wound healing issues at time of possible conversion (eg, wound dehiscence, wound infection, incisional hernia, lymphocele, seroma) 8. Elevated total cholesterol (\>350 mg/dL) and/or triglycerides (\>500 ng/dL) at time of possible conversion 9. Hypersensitivity to everolimus, sirolimus, or other rapamycin derivatives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Symptom Rating Scale | 3 months | Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Symptom Rating Scale | 1, 6, and 12 months | Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality. |
| Biopsy Proven Acute Rejection | 12 months | Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality. |
Countries
United States
Participant flow
Pre-assignment details
Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
Participants by arm
| Arm | Count |
|---|---|
| Interventional (EVR) Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus
Everolimus | 0 |
| Prior Agent (MPA) Patient will have baseline data collected while on MPA for comparison with EVR
Mycophenolic Acid | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Gastrointestinal Symptom Rating Scale
Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
Time frame: 3 months
Population: Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
Secondary
Biopsy Proven Acute Rejection
Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
Time frame: 12 months
Population: Trial was terminated with only 1 participant enrolled, no data is reported to protect patient confidentiality
Secondary
Gastrointestinal Symptom Rating Scale
Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
Time frame: 1, 6, and 12 months
Population: Trial was terminated with only 1 participant enrolled, no data is reported to protect patient confidentiality