Transplants and ImplantsPhase 4NCT00596947
Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant
A Phase 4 study testing prednisone, rabbit antithymocyte globulin and Tacrolimus in people with Transplants and Implants, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of the study was to determine if rapid discontinuation of corticosteroids (also known as prednisone withdrawal) and maintenance immunosuppression with Prograf (tacrolimus) and CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin) will give similar safety and efficacy… Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Transplants and Implants
- What is being tested?
- prednisone, rabbit antithymocyte globulin and Tacrolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Mar 2009
- 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 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First time kidney transplant recipients who receives a kidney from a cadaveric, living related or living unrelated donor
- Age greater than 18 years and less than 75 years
- Caucasian recipients
- Patients with current low panel reactive antibody (PRA) levels (<10%)
- Patients with signed and dated informed consent
- Women of childbearing potential must have a negative pregnancy test at baseline and agree to use a medically acceptable method of contraception throughout the treatment period.
Who cannot join
- Other than Caucasian ethnicity
- Patients with HIV+ or
- Patients with HbsAg+ or Hepatitis C positive
- Patients with a history of malignancy in the past 5 years
- Patients with active systemic or localized major infection
- Patients with a history of chronic steroid use for other diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Randomized, Prospective Single-center Study Comparing a Rapid Discontinuation of Corticosteroids (Steroid Withdrawal) With Corticosteroid Therapy in Kidney Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy
The purpose of the study was to determine if rapid discontinuation of corticosteroids (also known as prednisone withdrawal) and maintenance immunosuppression with Prograf (tacrolimus) and CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin) will give similar safety and efficacy results compared to continuation of corticosteroids (also known as prednisone maintenance) and standard maintenance immunosuppression with Prograf (tacrolimus), CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin).
Read the detailed description
Corticosteroids (one specific type is prednisone) have been used in clinical transplantation for more than 30 years. There are many side effects of corticosteroids including significant bone disease, diabetes (elevated blood sugar levels), fluid retention and hypertension (high blood pressure), psychosis, peptic ulcer disease, hyperlipidemia (elevated lipid levels such as cholesterol and triglycerides), obesity (overweight), acne, and susceptibility to infections. It is hoped that the new generation of potent immunosuppressive medications (such as Prograf and CellCept) will permit avoidance or withdrawal of corticosteroids for the majority of patients to avoid both short- and long-term complications of corticosteroid use in kidney transplant recipients.
- Conditions
- Transplants and Implants
- Being tested
- prednisone, rabbit antithymocyte globulin, Tacrolimus, Mycophenolate mofetil
- Keywords
- kidney transplantation, tacrolimus, Prograf, mycophenolate mofetil, CellCept, corticosteroid withdrawal, prednisone withdrawal, prednisone maintenance, rabbit antithymocyte globulin, Thymoglobulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisoneDrug
Also called Deltasone, Steroids, Methylprednisolone, Corticosteroids
In this group, participants had prednisone rapidly decreased until completely eliminated by day 6 after transplant. Participants began on 500mg of intravenous methylprednisolone on the day of transplant, followed by the following doses of oral prednisone: 160mg on day 1, 120mg on day 2, 80mg on day 3, 40mg on day 4, 20mg on day 5, none from day 6-on.
rabbit antithymocyte globulinDrug
Also called RATG, Thymoglobulin, Polyclonal antibody
Participants in both groups received 3 to 5 doses of an intravenous medication to prevent rejection called Thymoglobulin (rabbit antithymocyte globulin) as per our standard of care. This drug was dosed at 1.5 milligrams/killograms per dose and dosing was then based on body weight. The dose was decreased in half or held if the participant had a low white blood cell count or if the participant a low platelet count. The first dose was given intravenously in the operating room and subsequent intravenous doses were administered either while participants were inpatients or outpatients for a total of 3 to 5 doses for a total of up to 6mg/kg. The number of doses was based on transplant kidney function and risk factors for rejection.
TacrolimusDrug
Also called Prograf
Participants in both groups received tacrolimus per our standard of care. This medication helped to prevent rejection and was initially dosed at 0.1-0.2 milligrams/killograms/day in two divided doses, given orally, based on participant's body weight. We then looked at the trough levels of this medication(the lowest level before the next dose), and aimed to keep the trough level between 5-10 nanograms/milliliter throughout the study.
PrednisoneDrug
Also called Deltasone, Steroids, Methylprednisolone, Corticosteroids
Participants in this group continued on prednisone indefinitely. Participants began with 500mg of intravenous methylprednisolone on the day of transplant, followed by the following doses of oral prednisone: 160mg on day 1, 120mg on day 2, 80mg on day 3, 40mg on day 4, 20 mg days 5-9, 15 mg day 10-19, 10 mg day 20-24, 7.5 mg day 25-29, and 5mg from day 30-on indefinitely.
Also called mmf, CellCept
Participants in both groups received mycophenolate mofetil by mouth twice daily indefinitely. Dosing for patients in the Prednisone withdrawal group was 1000mg orally twice daily. The dose was decreased or held at the discretion of the physician, for side effects such as low white blood cell count, or low platelet count, or if the participant experienced stomach side effects such as heartburn, nausea, vomiting or diarrhea.
Also called mmf, CellCept
Participants in both groups received mycophenolate mofetil by mouth twice daily indefinitely. Dosing for patients in the Prednisone maintenance group was 500 mg orally twice daily. The dose was decreased or held at the discretion of the physician, for side effects such as low white blood cell count, or low platelet count, or if the participant experienced stomach side effects such as heartburn, nausea, vomiting or diarrhea.
| Study group | Role | What they receive |
|---|---|---|
| Prednisone Withdrawal | Experimental | Participants randomized to the prednisone withdrawal group, received 4 medications to prevent rejection. Thymoglobulin (rabbit antithymocyte globulin) was given intravenously in the operating room at the time of transplant. Subsequent intravenous doses were administered to participants an inpatient or outpatient for a total of 3 to 5 doses. Participants also began taking Prograf (tacrolimus) and CellCept (mycophenolate mofetil)orally within 24 hours of transplant and continued indefinitely. The steroids were initially given in the operating room intravenously at time of transplant as Solu-medrol (methylprednisolone)and were then switched to daily oral prednisone doses. The participant's dose of prednisone was rapidly decreased until it was completely eliminated by day 6 post-transplant. Receives: Drug: prednisone; Drug: rabbit antithymocyte globulin; Drug: Tacrolimus; Drug: Mycophenolate mofetil |
| Prednisone Maintenance | Active comparator | Participants randomized to the prednisone maintenance group, received 4 medications to prevent rejection. Thymoglobulin (rabbit antithymocyte globulin) was initiated intravenously in the operating room at the time of transplant. Subsequent intravenous doses were administered an inpatient or outpatient for a total of 3 to 5 doses. Participants began taking Prograf (tacrolimus) and CellCept (mycophenolate mofetil)orally within 24 hours of transplant and continued on them indefinitely. The steroids were initially given intravenously in the operating room at time of transplant as Solu-medrol (methylprednisolone) and were then switched to daily oral prednisone tablets. Participants remained on all drugs according to their doctor's standard of care, and the prednisone was not be eliminated. Receives: Drug: rabbit antithymocyte globulin; Drug: Tacrolimus; Drug: Prednisone; Drug: Mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Acute Rejection Episodes
Acute rejection episodes would have been measured by the number of participants who underwent a kidney transplant biopsy, and had the results of the biopsy reported as acute rejection by the transplant pathologist. Biopsies were only performed if clinically indicated. The cumulative number of participants with recorded rejection episodes by 6 and 12 months post-transplant would have been reported.
Measured: 6 and 12 months post-transplant
The Number of Participants With Graft Survival
The number of participants who did not experience graft failure (defined as return to dialysis) at 6 and 12 months would have been reported.
Measured: 6 and 12 months
Participant Survival
The number of participants alive at 6 and 12 months post-transplant would have been posted as a measure of patient survival.
Measured: 6 and 12 months
Secondary outcomes (15)
The Number of Participants With Treatment Failures
This measure was defined as the percentage of participants that did not remain on initial therapy (ie were withdrawn from each arm of the trial)
Measured: 12 months
Length of Hospital Stay After Transplant
The length of the hospital stay would have assessed the number of days a participant was in the hospital after the kidney transplant was performed. This is calculated from date of admission to date of discharge.
Measured: 12 months
The Number of Participants With Hospital Readmissions
The number of readmissions during the study period for each participant would have been assessed, as well as the reason for readmissions.
Measured: 12 months
The Length of Stay Associated With Hospital Readmissions
The time from admission to discharge for each readmission for patients readmitted in the first 12 months post-transplant.
Measured: 12 months
Participant Renal Function as Measured by MDRD Formula
The above methods focus on estimating or determining actual glomerular filtration rate (GFR) (or renal function) of the kidney transplant. The MDRD (Modification of Diet in Renal Disease) calculation includes age, sex and serum creatinine would have provided an estimate of GFR. This was to be performed at 3,6 and 12 months post-transplant.
Measured: 3, 6 and 12 months
Participant Renal Function as Measured by 24 Hour Urine Collection
Results would have been reported from patients undergoing 24 hour urine collections at 3 and 12 months post-transplant. This is a way to measure glomerular function rate (GFR) or renal function.
Measured: 3 and 12 months post-transplant
The Number of Participants With the Need for Rabbit Antithymocyte Globulin to Treat Rejection Episodes.
The incidence and severity of rejection episodes per participant would have been identified by kidney transplant biopsy results read by a transplant pathologist. Treatment of rejection episodes in each participant would have been determined by the treating transplant physician.
Measured: 12 months
The Number of Participants With Leukopenia
All participants would have been assessed for the presence at any time during the trial of: leukopenia (defined by lab results as a white count less than 3,000 cells/uL).
Measured: 12 months
The Number of Participants With Infections
Participants would have been monitored throughout the study for any infectious complications as confirmed by the principal investigator. Patients would have been monitored by urine cytology and blood polymerase chain reaction for BK virus at baseline, and months 3, 6 and 12 post-transplant.
Measured: 12 months
The Number of Participants With Malignancy
Participants would have been monitored throughout the study with any reports of malignancy being confirmed by principal investigator.
Measured: 12 months
The Number of Participants With Hypertension
The number of participants who developed hypertension defined as blood pressure greater than 140/90 throughout the first 12 months of the study.
Measured: 12 months
The Number of Participants With Hyperlipidemia
Fasting lipid profiles were to be performed at 3,6 and 12 months post-transplant. Definitions based on ATP III guidelines.
Measured: 12 months
The Number of Participants With Bone Disease
Bone densitometry by Computed tomography of peripheral skeleton and DEXA scans were performed at baseline (within one month after transplant) Urine and blood samples to measure markers of bone turnover: Alkaline phosphatase, pyridinoline, serum 1-25 vit D 3 levels (calcitriol) and 25 hydroxy vit D (calcidiol) levels and serum osteocalcin levels were drawn at baseline, 3, 6, 12 and 24 months.
Measured: baseline (within 1 month post-transplant), 3, 6, 12 and 24 months
The Number of Participants With Post Transplant Diabetes Mellitus
Glucose tolerance test performed in non-diabetic participants only at pre transplant in living donor recipients and at baseline (within 1 mo after transplant) and 6 mo and 12 months. Blood test for hemoglobin A1C in non diabetic participants only: at baseline, 3, 6, and 12 months.
Insulin and C peptide levels at baseline, 3,6 and 12 months in all participants.
Measured: pre-transplant in living donor recipients, baseline (within one month post-transplant) and at 3, 6 and 12 months
The Number of Participants With Weight Gain
Height, weight will be used to calculate change in BMI for all participants.
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 posted17 Jan 2008 (estimated)
- Study startOct 2005
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: due to low study enrollment
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 Transplants and ImplantsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simin Goral, University of Pennsylvania
- Investigators
- Simin Goral, MD, Principal investigator, University of Pennsylvania-Renal Electrolyte and Hypertension Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596947
- Sponsor's protocol ID
- 803242
- Status last verified
- Mar 2017
- First submitted
- 8 Jan 2008
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective Single-center Study Comparing a Rapid Discontinuation of Corticosteroids (Steroid Withdrawal) With Corticosteroid Therapy in Kidney Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy
- ClinicalTrials.gov ID
- NCT00596947
- Acronym / sponsor ID
- 803242
- Conditions
- Transplants and Implants
- Keywords
- kidney transplantation, tacrolimus, Prograf, mycophenolate mofetil, CellCept, corticosteroid withdrawal, prednisone withdrawal, prednisone maintenance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to low study enrollment
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Posted 21 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was to determine if rapid discontinuation of corticosteroids (also known as prednisone withdrawal) and maintenance immunosuppression with Prograf (tacrolimus) and CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin) will give similar safety and efficacy results compared to continuation of corticosteroids (also known as prednisone maintenance) and standard maintenance immunosuppression with Prograf (tacrolimus), CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin).
Detailed description
Corticosteroids (one specific type is prednisone) have been used in clinical transplantation for more than 30 years. There are many side effects of corticosteroids including significant bone disease, diabetes (elevated blood sugar levels), fluid retention and hypertension (high blood pressure), psychosis, peptic ulcer disease, hyperlipidemia (elevated lipid levels such as cholesterol and triglycerides), obesity (overweight), acne, and susceptibility to infections. It is hoped that the new generation of potent immunosuppressive medications (such as Prograf and CellCept) will permit avoidance or withdrawal of corticosteroids for the majority of patients to avoid both short- and long-term complications of corticosteroid use in kidney transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone Withdrawal | Experimental | Drug: prednisone, Drug: rabbit antithymocyte globulin, Drug: Tacrolimus, Drug: Mycophenolate mofetilParticipants randomized to the prednisone withdrawal group, received 4 medications to prevent rejection. Thymoglobulin (rabbit antithymocyte globulin) was given intravenously in the operating room at the time of transplant. Subsequent intravenous doses were administered to participants an inpatient or outpatient for a total of 3 to 5 doses. Participants also began taking Prograf (tacrolimus) and CellCept (mycophenolate mofetil)orally within 24 hours of transplant and continued indefinitely. The steroids were initially given in the operating room intravenously at time of transplant as Solu-medrol (methylprednisolone)and were then switched to daily oral prednisone doses. The participant's dose of prednisone was rapidly decreased until it was completely eliminated by day 6 post-transplant. |
| Prednisone Maintenance | Active comparator | Drug: rabbit antithymocyte globulin, Drug: Tacrolimus, Drug: Prednisone, Drug: Mycophenolate mofetilParticipants randomized to the prednisone maintenance group, received 4 medications to prevent rejection. Thymoglobulin (rabbit antithymocyte globulin) was initiated intravenously in the operating room at the time of transplant. Subsequent intravenous doses were administered an inpatient or outpatient for a total of 3 to 5 doses. Participants began taking Prograf (tacrolimus) and CellCept (mycophenolate mofetil)orally within 24 hours of transplant and continued on them indefinitely. The steroids were initially given intravenously in the operating room at time of transplant as Solu-medrol (methylprednisolone) and were then switched to daily oral prednisone tablets. Participants remained on all drugs according to their doctor's standard of care, and the prednisone was not be eliminated. |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First time kidney transplant recipients who receives a kidney from a cadaveric, living related or living unrelated donor
- Age greater than 18 years and less than 75 years
- Caucasian recipients
- Patients with current low panel reactive antibody (PRA) levels (<10%)
- Patients with signed and dated informed consent
Key exclusion criteria (6 listed)
- Other than Caucasian ethnicity
- Patients with HIV+ or
- Patients with HbsAg+ or Hepatitis C positive
- Patients with a history of malignancy in the past 5 years
- Patients with active systemic or localized major infection
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 |
|---|---|---|
| prednisoneAlso: Deltasone, Steroids, Methylprednisolone, CorticosteroidsIn this group, participants had prednisone rapidly decreased until completely eliminated by day 6 after transplant. Participants began on 500mg of intravenous methylprednisolone on the day of transplant, followed by the following doses of oral prednisone: 160mg on day 1, 120mg on day 2, 80mg on day 3, 40mg on day 4, 20mg on day 5, none from day 6-on. | Drug | Prednisone Withdrawal |
| rabbit antithymocyte globulinAlso: RATG, Thymoglobulin, Polyclonal antibodyParticipants in both groups received 3 to 5 doses of an intravenous medication to prevent rejection called Thymoglobulin (rabbit antithymocyte globulin) as per our standard of care. This drug was dosed at 1.5 milligrams/killograms per dose and dosing was then based on body weight. The dose was decreased in half or held if the participant had a low white blood cell count or if the participant a low platelet count. The first dose was given intravenously in the operating room and subsequent intravenous doses were administered either while participants were inpatients or outpatients for a total of 3 to 5 doses for a total of up to 6mg/kg. The number of doses was based on transplant kidney function and risk factors for rejection. | Drug | Prednisone Maintenance, Prednisone Withdrawal |
| TacrolimusAlso: PrografParticipants in both groups received tacrolimus per our standard of care. This medication helped to prevent rejection and was initially dosed at 0.1-0.2 milligrams/killograms/day in two divided doses, given orally, based on participant's body weight. We then looked at the trough levels of this medication(the lowest level before the next dose), and aimed to keep the trough level between 5-10 nanograms/milliliter throughout the study. | Drug | Prednisone Maintenance, Prednisone Withdrawal |
| PrednisoneAlso: Deltasone, Steroids, Methylprednisolone, CorticosteroidsParticipants in this group continued on prednisone indefinitely. Participants began with 500mg of intravenous methylprednisolone on the day of transplant, followed by the following doses of oral prednisone: 160mg on day 1, 120mg on day 2, 80mg on day 3, 40mg on day 4, 20 mg days 5-9, 15 mg day 10-19, 10 mg day 20-24, 7.5 mg day 25-29, and 5mg from day 30-on indefinitely. | Drug | Prednisone Maintenance |
| Mycophenolate mofetilAlso: mmf, CellCeptParticipants in both groups received mycophenolate mofetil by mouth twice daily indefinitely. Dosing for patients in the Prednisone withdrawal group was 1000mg orally twice daily. The dose was decreased or held at the discretion of the physician, for side effects such as low white blood cell count, or low platelet count, or if the participant experienced stomach side effects such as heartburn, nausea, vomiting or diarrhea. | Drug | Prednisone Withdrawal |
| Mycophenolate mofetilAlso: mmf, CellCeptParticipants in both groups received mycophenolate mofetil by mouth twice daily indefinitely. Dosing for patients in the Prednisone maintenance group was 500 mg orally twice daily. The dose was decreased or held at the discretion of the physician, for side effects such as low white blood cell count, or low platelet count, or if the participant experienced stomach side effects such as heartburn, nausea, vomiting or diarrhea. | Drug | Prednisone Maintenance |
Primary outcome
The Number of Participants With Acute Rejection Episodes
Time frame: 6 and 12 months post-transplant
Acute rejection episodes would have been measured by the number of participants who underwent a kidney transplant biopsy, and had the results of the biopsy reported as acute rejection by the transplant pathologist. Biopsies were only performed if clinically indicated. The cumulative number of participants with recorded rejection episodes by 6 and 12 months post-transplant would have been reported.
The Number of Participants With Graft Survival
Time frame: 6 and 12 months
The number of participants who did not experience graft failure (defined as return to dialysis) at 6 and 12 months would have been reported.
Participant Survival
Time frame: 6 and 12 months
The number of participants alive at 6 and 12 months post-transplant would have been posted as a measure of patient survival.
15 secondary outcomes
The Number of Participants With Treatment Failures
Time frame: 12 months
Length of Hospital Stay After Transplant
Time frame: 12 months
The Number of Participants With Hospital Readmissions
Time frame: 12 months
The Length of Stay Associated With Hospital Readmissions
Time frame: 12 months
Participant Renal Function as Measured by MDRD Formula
Time frame: 3, 6 and 12 months
Participant Renal Function as Measured by 24 Hour Urine Collection
Time frame: 3 and 12 months post-transplant
The Number of Participants With the Need for Rabbit Antithymocyte Globulin to Treat Rejection Episodes.
Time frame: 12 months
The Number of Participants With Leukopenia
Time frame: 12 months
The Number of Participants With Infections
Time frame: 12 months
The Number of Participants With Malignancy
Time frame: 12 months
The Number of Participants With Hypertension
Time frame: 12 months
The Number of Participants With Hyperlipidemia
Time frame: 12 months
The Number of Participants With Bone Disease
Time frame: baseline (within 1 month post-transplant), 3, 6, 12 and 24 months
The Number of Participants With Post Transplant Diabetes Mellitus
Time frame: pre-transplant in living donor recipients, baseline (within one month post-transplant) and at 3, 6 and 12 months
The Number of Participants With Weight Gain
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 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Simin Goral, MD principal investigator
University of Pennsylvania-Renal Electrolyte and Hypertension Division
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 prednisone, rabbit antithymocyte globulin and Tacrolimus in people with Transplants and Implants, run by University of Pennsylvania 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 6 inclusion and 6 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 15 May 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.
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 21 Mar 2011). 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?
The Number of Participants With Acute Rejection Episodes (time frame: 6 and 12 months post-transplant). The study lists 3 primary outcomes in all. 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 15 May 2017.