A Phase 4 interventional study of Enteric coated mycophenolate sodium and Mycophenolate mofetil in Transplants and Implants, sponsored by University of Pennsylvania. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by University of Pennsylvania · Phase 4, Interventional, and Treatment
Myfortic (enteric-coated mycophenolate sodium) has been shown to have similar effectiveness to CellCept (mycophenolate mofetil) in preventing rejection in kidney transplant recipients. However, enteric coated mycophenolate sodium has been thought to possibly be associated with fewer gastrointestinal side effects. Mycophenolate mofetil and enteric coated mycophenolate sodium pharmacokinetics (how the drug is absorbed and broken down) have not been well-studied in African American kidney transplant recipients. The investigators are interested in studying enteric coated mycophenolate sodium and mycophenolate mofetil pharmacokinetics and gastrointestinal side effects in African American kidney transplant recipients.
African American patients often experience more gastrointestinal (GI) complications after kidney transplant than Caucasian patients. In addition, African American kidney transplant recipients also experience a higher incidence of acute rejection and have worse outcomes compared with all other ethnic groups. Reasons accounting for these differences are not well understood.
In light of the increased risk of GI complications in African American patients, we will compare in a pilot study, different regimens (described below) that we commonly use in our clinical practice in this population. As part of this study, patients will also fill out a GSRS survey at specified time points to help describe gastrointestinal side effects after transplant.
Pharmacokinetic studies (studies looking at how the drugs are absorbed and broken down) for mycophenolate mofetil or enteric coated mycophenolate sodium have largely been performed in Caucasian populations. There is little information available in African-American patients. This is particularly concerning in the face of the worst clinical outcomes observed after transplantation in African American kidney transplant recipients.
Comparisons: Patients will be randomized to one of two groups
Since toxicity of mycophenolate mofetil and enteric coated mycophenolate sodium may be influenced by pharmacokinetics (studies that look at how the drugs are absorbed and broken down) of these respective drugs, we will compare the pharmacokinetics of enteric coated mycophenolate sodium and mycophenolate mofetil in a subset of patients. This pharmacokinetic data may have the additional valuable benefit of helping to optimize dosing parameters for mycophenolate mofetil and enteric coated mycophenolate sodium in African American kidney transplant patients in the future.
University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this group will receive Myfortic (enteric-coated mycophenolate sodium) at a target dose of 720 mg orally twice daily for 6 months after transplant.
Drug: Enteric coated mycophenolate sodium
Patients in this group will receive CellCept (mycophenolate mofetil) or its generic equivalent manufactured by Sandoz, at a target dose of 1000 mg orally twice daily for 6 months after transplant.
Drug: Mycophenolate mofetil
Patients in this group will receive Myfortic (enteric-coated mycophenolate sodium) in combination with Thymoglobulin (rabbit Anti-thymocyte globulin) induction immunosuppression, Prograf (tacrolimus) or its generic equivalent, and corticosteroid immunosuppression.
Also known as: Myfortic
Patients in this group will receive CellCept (mycophenolate mofetil) or its generic equivalent formulation manufactured by Sandoz, in combination with Thymoglobulin (rabbit Anti-thymocyte globulin) induction immunosuppression, Prograf (tacrolimus) or its generic equivalent, and corticosteroid immunosuppression.
Also known as: CellCept
Gastrointestinal Toxicity Due to Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Formulation Manufactured by Sandoz
At 24 weeks, we assessed the number of patients at this timepoint who required permanent dose decrease or discontinuation of either enteric coated mycophenolate sodium or mycophenolate mofetil or its generic equivalent formulation manufactured by Sandoz related to gastrointestinal toxicity.
Time frame: 6 months
The Incidence of the Requirement of Full Dose Proton Pump Inhibitors in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz
If patients were not on any medications from a medication class known as H-2 antagonists, they were started on ranitidine 150 mg orally twice daily after transplant (with dose adjusted for renal function). Patients were excluded if they were on proton pump inhibitor at time of study screening, however some patients required addition of proton pump inhibitor post-study enrollment. If a patient had upper gastrointestinal side effects such as acid reflux unreleived on ranitidine therapy or nausea, they were switched to a proton pump inhibitor.
Time frame: 6 months
The Incidence of Intolerance (Defined as Transient Dose Reduction or Transient Discontinuation of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz
The incidence of intolerance was defined as transient dose reduction or transient discontinuation of enteric coated mycophenolate sodium or mycophenolate mofetil or its generic equivalent manufactured by Sandoz meaning doses could subsequently be resumed or increased back to original starting dose, once intolerance resolved.
Time frame: 6 months
Gastrointestinal Symptom Rating Scale (GSRS) Score Changes From Baseline to 24 Weeks After Transplant in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item self-administered questionnaire to assess symptoms associated with common gastrointestinal (GI) disorders, and has been validated in renal transplant recipients. It uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one and the patient grades symptoms based on the past 7 days. A score of ≥ 2 indicates the presence of GI symptoms. Higher values indicate more unfavorable conditions. The questionairre is divided into 5 sub-scales: diarrhea, indigestion, constipation, abdominal pain, and reflux and a mean score is calculated for each dimension. The lowest mean score possible for each dimension is 1 and the highest is 7. Patients completed a GSRS survey at baseline (pre-transplant to two days after transplant), and at weeks 1,4,12 and 24 after transplant.
Time frame: baseline (pre-transplant to two days after transplant) and at 6 months after transplant.
The Incidence of the Occurrence of Upper Gastrointestinal Symptoms Per GSRS Scale Ratings in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Formulation Manufactured by Sandoz
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item self-administered questionnaire to assess symptoms associated with common gastrointestinal (GI) disorders, and has been validated in renal transplant recipients. It uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one and the patient grades symptoms based on the past 7 days. A score of ≥ 2 indicates the presence of GI symptoms. Higher values indicate more unfavorable conditions. The questionairre is divided into 5 sub-scales: diarrhea, constipation, abdominal pain, indigestion and reflux and a mean score is calculated for each dimension. The lowest mean score possible for each dimension is 1 and the highest is 7. Patients completed a GSRS survey at baseline (pre-transplant to two days after transplant), and at weeks 1,4,12 and 24 post-transplant.
Time frame: 6 months
The Incidence of the Occurrence of Lower Gastrointestinal Symptoms Per GSRS Scale Ratings in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item self-administered questionnaire to assess symptoms associated with common gastrointestinal (GI) disorders, and has been validated in renal transplant recipients. It uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one and the patient grades symptoms based on the past 7 days. A score of ≥ 2 indicates the presence of GI symptoms. Higher values indicate more unfavorable conditions. The questionairre is divided into 5 sub-scales: diarrhea, constipation, abdominal pain, indigestion and reflux and a mean score is calculated for each dimension. The lowest mean score possible for each dimension is 1 and the highest is 7. Patients completed a GSRS survey at baseline (pre-transplant to two days after transplant), and at weeks 1,4,12 and 24 post-transplant. Patients who withdrew from the study only had data included up to the point of withdraw. No values were carried forward.
Time frame: 6 months
The Incidence of Rejection in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz.
All rejection episodes of the kidney transplant were proven by kidney transplant biopsy and were measured at 24 weeks for all patients still participating in the study at that timepoint.
Time frame: 6 months
Serum Creatinine in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz
Serum creatinine lab values were used as part of a measure of renal function at 24 weeks for any patient that was still participating in the study at this time-point.
Time frame: 6 months
Modification of Diet and Renal Disease (MDRD) Measured Glomerular Filtration Rates in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz
Modification of Diet and Renal Disease (MDRD) Measured Glomerular Filtration Rates were used as part of a measure of renal function and measured at 24 weeks in patients who were still participating in the study at that point.
Time frame: 6 months
Pharmacokinetics (Mycophenolic Acid Trough Levels) of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz in a Sub-set of Patients
Pharmacokinetics is the study of how a drug is absorbed and broken down in the body. Pharmacokinetics of enteric coated mycophenolate sodium and mycophenolate mofetil are measured by a level called mycophenolic acid level. Mycophenolic acid levels in this pharmacokinetic study were drawn starting in the morning at time zero (immediately prior to morning dose, also known as trough), then at 0.5, 1,1.5, 2, 2.5, 3,3.5,4,6, 8 and 12 hours post dose. Data was also dose-normalized (concentration was divided by dose).
Time frame: 1 and 6 months
Pharmacokinetics (Mycophenolic Acid Maximum Concentration) of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz in a Sub-set of Patients
Pharmacokinetics is the study of how a drug is absorbed and broken down in the body. Pharmacokinetics of Enteric-Coated Mycophenolate Sodium or Mycophenolate Mofetil are measured by a level called mycophenolic acid level. Mycophenolic acid levels in this pharmacokinetic study were drawn starting in the morning at time zero (immediately prior to morning dose, also known as trough), then at 0.5, 1,1.5, 2, 2.5, 3,3.5,4,6, 8 and 12 hours post dose. Data was also dose-normalized (concentration was divided by dose).A mycophenolic acid drawn at the peak level is called C Max or maximum concentration.
Time frame: 1 and 6 months
Pharmacokinetics (Mycophenolic Acid Area Under the Curve) of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz in a Sub-set of Patients
Pharmacokinetics is the study of how a drug is absorbed and broken down in the body. Pharmacokinetics of Enteric-Coated Mycophenolate Sodium or Mycophenolate Mofetil are measured by a level called mycophenolic acid level. Mycophenolic acid levels in this pharmacokinetic study were drawn starting in the morning at time zero (immediately prior to morning dose, also known as trough), then at 0.5, 1,1.5, 2, 2.5, 3,3.5,4,6, 8 and 12 hours post dose. Data was also dose-normalized (concentration was divided by dose). A mycophenolic acid area under the curve value, also known as AUC represents drug exposure.
Time frame: 1 and 6 months
Recruitment occured at the Hospital of the University of Pennsylvania March 2007-June 2010. Living donor kidney recipients were approached in clinic at pre-transplant visit (within 30 days or less of transplant. Recipients of deceased donor kidney transplants were approached inpatient at transplant or 2 days thereafter.
| Milestone | Myfortic Comparator Group | CellCept Comparator Group |
|---|---|---|
| Started | 18 | 19 |
| Consented to pharmacokinetic study | 11 | 10 |
| Completed 0/2 pk visits | 3 | 4 |
| Completed 1/2 pk visits | 1 | 1 |
| Completed 2/2 pk visits | 7 | 5 |
| Completed | 16 | 15 |
| Not completed | 2 | 4 |
| Withdrew: Adverse event | 2 | 2 |
| Withdrew: Withdrawal by subject | 0 | 2 |
At 24 weeks, we assessed the number of patients at this timepoint who required permanent dose decrease or discontinuation of either enteric coated mycophenolate sodium or mycophenolate mofetil or its generic equivalent formulation manufactured by Sandoz related to gastrointestinal toxicity.
| participants | Myfortic Comparator Group | CellCept Comparator Group |
|---|---|---|
| Gastrointestinal Toxicity Due to Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Formulation Manufactured by Sandoz | 9 | 4 |
If patients were not on any medications from a medication class known as H-2 antagonists, they were started on ranitidine 150 mg orally twice daily after transplant (with dose adjusted for renal function). Patients were excluded if they were on proton pump inhibitor at time of study screening, however some patients required addition of proton pump inhibitor post-study enrollment. If a patient had upper gastrointestinal side effects such as acid reflux unreleived on ranitidine therapy or nausea, they were switched to a proton pump inhibitor.
| participants | Myfortic Comparator Group | CellCept Comparator Group |
|---|---|---|
| The Incidence of the Requirement of Full Dose Proton Pump Inhibitors in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz | 3 | 1 |
The incidence of intolerance was defined as transient dose reduction or transient discontinuation of enteric coated mycophenolate sodium or mycophenolate mofetil or its generic equivalent manufactured by Sandoz meaning doses could subsequently be resumed or increased back to original starting dose, once intolerance resolved.
| participants | Myfortic Comparator Group | CellCept Comparator Group |
|---|---|---|
| The Incidence of Intolerance (Defined as Transient Dose Reduction or Transient Discontinuation of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz | 1 | 0 |
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item self-administered questionnaire to assess symptoms associated with common gastrointestinal (GI) disorders, and has been validated in renal transplant recipients. It uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one and the patient grades symptoms based on the past 7 days. A score of ≥ 2 indicates the presence of GI symptoms. Higher values indicate more unfavorable conditions. The questionairre is divided into 5 sub-scales: diarrhea, indigestion, constipation, abdominal pain, and reflux and a mean score is calculated for each dimension. The lowest mean score possible for each dimension is 1 and the highest is 7. Patients completed a GSRS survey at baseline (pre-transplant to two days after transplant), and at weeks 1,4,12 and 24 after transplant.
| Participants | Myfortic Comparator Group | CellCept Comparator Group |
|---|---|---|
| Worsening of GSRS Score pre-transplant-wk 24 | 4 | 4 |
| No Worsening of GSRS Score pre-transplant-wk 24 | 13 | 10 |
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item self-administered questionnaire to assess symptoms associated with common gastrointestinal (GI) disorders, and has been validated in renal transplant recipients. It uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one and the patient grades symptoms based on the past 7 days. A score of ≥ 2 indicates the presence of GI symptoms. Higher values indicate more unfavorable conditions. The questionairre is divided into 5 sub-scales: diarrhea, constipation, abdominal pain, indigestion and reflux and a mean score is calculated for each dimension. The lowest mean score possible for each dimension is 1 and the highest is 7. Patients completed a GSRS survey at baseline (pre-transplant to two days after transplant), and at weeks 1,4,12 and 24 post-transplant.
| Participants | Myfortic Comparator Group | CellCept Comparator Group |
|---|---|---|
| Number of Participants with Upper GI symptoms | 8 | 11 |
| Number of Participants without Upper GI symptoms | 9 | 3 |
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item self-administered questionnaire to assess symptoms associated with common gastrointestinal (GI) disorders, and has been validated in renal transplant recipients. It uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one and the patient grades symptoms based on the past 7 days. A score of ≥ 2 indicates the presence of GI symptoms. Higher values indicate more unfavorable conditions. The questionairre is divided into 5 sub-scales: diarrhea, constipation, abdominal pain, indigestion and reflux and a mean score is calculated for each dimension. The lowest mean score possible for each dimension is 1 and the highest is 7. Patients completed a GSRS survey at baseline (pre-transplant to two days after transplant), and at weeks 1,4,12 and 24 post-transplant. Patients who withdrew from the study only had data included up to the point of withdraw. No values were carried forward.
| Participants | Myfortic Comparator Group | CellCept Comparator Group |
|---|---|---|
| Number of Participants with Lower GI symptoms | 8 | 9 |
| Number of Participants without Lower GI symptoms | 9 | 5 |
All rejection episodes of the kidney transplant were proven by kidney transplant biopsy and were measured at 24 weeks for all patients still participating in the study at that timepoint.
| participants | Myfortic Comparator Group | CellCept Comparator Group |
|---|---|---|
| The Incidence of Rejection in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz. | 2 | 1 |
Serum creatinine lab values were used as part of a measure of renal function at 24 weeks for any patient that was still participating in the study at this time-point.
| serum creatinine mg/dL | Myfortic Comparator Group | CellCept Comparator Group |
|---|---|---|
| Serum Creatinine in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz | 1.9 ± 3.0 | 1.9 ± 0.9 |
Modification of Diet and Renal Disease (MDRD) Measured Glomerular Filtration Rates were used as part of a measure of renal function and measured at 24 weeks in patients who were still participating in the study at that point.
| MDRD (mL/min/1.73m2) | Myfortic Comparator Group | CellCept Comparator Group |
|---|---|---|
| Modification of Diet and Renal Disease (MDRD) Measured Glomerular Filtration Rates in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz | 59.6 ± 22.5 | 54.8 ± 20.0 |
Pharmacokinetics is the study of how a drug is absorbed and broken down in the body. Pharmacokinetics of enteric coated mycophenolate sodium and mycophenolate mofetil are measured by a level called mycophenolic acid level. Mycophenolic acid levels in this pharmacokinetic study were drawn starting in the morning at time zero (immediately prior to morning dose, also known as trough), then at 0.5, 1,1.5, 2, 2.5, 3,3.5,4,6, 8 and 12 hours post dose. Data was also dose-normalized (concentration was divided by dose).
| mg/L | Myfortic Comparator Group | CellCept Comparator Group |
|---|---|---|
| Mycophenolic Acid Trough (mg/L) at week 4 | 2.4 ± 1.6 | 1.9 ± 1.3 |
| Mycophenolic Acid Trough(mg/L) at week 24 | 1.9 ± 1.5 | 1.5 ± 1.1 |
Pharmacokinetics is the study of how a drug is absorbed and broken down in the body. Pharmacokinetics of Enteric-Coated Mycophenolate Sodium or Mycophenolate Mofetil are measured by a level called mycophenolic acid level. Mycophenolic acid levels in this pharmacokinetic study were drawn starting in the morning at time zero (immediately prior to morning dose, also known as trough), then at 0.5, 1,1.5, 2, 2.5, 3,3.5,4,6, 8 and 12 hours post dose. Data was also dose-normalized (concentration was divided by dose).A mycophenolic acid drawn at the peak level is called C Max or maximum concentration.
| mg/L | Myfortic Comparator Group | CellCept Comparator Group |
|---|---|---|
| Mycophenolic Acid C max (mg/L) at week 4 | 4.3 ± 1.5 | 10.5 ± 4.1 |
| Mycophenolic Acid C max (mg/L) at week 24 | 6.4 ± 3.5 | 13.9 ± 6.0 |
Pharmacokinetics is the study of how a drug is absorbed and broken down in the body. Pharmacokinetics of Enteric-Coated Mycophenolate Sodium or Mycophenolate Mofetil are measured by a level called mycophenolic acid level. Mycophenolic acid levels in this pharmacokinetic study were drawn starting in the morning at time zero (immediately prior to morning dose, also known as trough), then at 0.5, 1,1.5, 2, 2.5, 3,3.5,4,6, 8 and 12 hours post dose. Data was also dose-normalized (concentration was divided by dose). A mycophenolic acid area under the curve value, also known as AUC represents drug exposure.
| mg*hr/L | Myfortic Comparator Group | CellCept Comparator Group |
|---|---|---|
| Mycophenolic Acid AUC (mg*hr/L) at week 4 | 23.9 ± 10.9 | 33.8 ± 18.4 |
| Mycophenolic Acid AUC (mg*hr/L) at week 24 | 21.1 ± 11.7 | 42.4 ± 33.2 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Myfortic Comparator Group | — | 18/18 (100%) | 18/18 (100%) |
| CellCept Comparator Group | — | 19/19 (100%) | 17/19 (89.5%) |
| Event | Myfortic Comparator Group | CellCept Comparator Group |
|---|---|---|
| Bacterial infectionsInfections and infestations | 6/18 | 5/19 |
| graft dysfunction not found to be related to rejectionRenal and urinary disorders | 3/18 | 6/19 |
| diabetic complicationsMetabolism and nutrition disorders | 1/18 | 4/19 |
| non-infectious related diarrheaGastrointestinal disorders | 2/18 | 3/19 |
| anemia managed during hospitalizationRenal and urinary disorders | 2/18 | 3/19 |
| heart complicationsCardiac disorders | 2/18 | 1/19 |
| high blood pressureCardiac disorders | 2/18 | 0/19 |
| lymphoceleInjury, poisoning and procedural complications | 0/18 | 2/19 |
| high potassium (hyperkalemia) requiring hospitalization for managementMetabolism and nutrition disorders | 1/18 | 2/19 |
| Viral infectionsInfections and infestations | 1/18 | 2/19 |
| Event | Myfortic Comparator Group | CellCept Comparator Group |
|---|---|---|
| delayed graft function of renal transplantRenal and urinary disorders | 9/18 | 8/19 |
| DiarrheaGastrointestinal disorders | 7/18 | 6/19 |
| high potassium (hyperkalemia) not requiring hospitalizationMetabolism and nutrition disorders | 5/18 | 5/19 |
| low red blood cell count (anemia)Blood and lymphatic system disorders | 5/18 | 3/19 |
| HeartburnGastrointestinal disorders | 3/18 | 5/19 |
| Diabetic ComplicationsEndocrine disorders | 4/18 | 0/19 |
| low white blood cell count (leukopenia)Blood and lymphatic system disorders | 4/18 | 3/19 |
| bacterial infection not requiring hospitalizationInfections and infestations | 3/18 | 0/19 |
| shortness of breath and fluid related weight gain not requiring hospitalizationCardiac disorders | 2/18 | 0/19 |
| viral cold infectionInfections and infestations | 2/18 | 0/19 |
| Age, Categorical(Participants) | Myfortic Comparator Group | CellCept Comparator Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 19 | 37 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Myfortic Comparator Group | CellCept Comparator Group | Total |
|---|---|---|---|
| Mean | 47.9 ± 9.3 | 52.4 ± 13.0 | 50.3 ± 11.5 |
| Sex: Female, Male(Participants) | Myfortic Comparator Group | CellCept Comparator Group | Total |
|---|---|---|---|
| Female | 7 | 6 | 13 |
| Male | 11 | 13 | 24 |
| Region of Enrollment(participants) | Myfortic Comparator Group | CellCept Comparator Group | Total |
|---|---|---|---|
| United States | 18 | 19 | 37 |
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Pennsylvania