Kidney TransplantationPhase 2NCT01292226
A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).
A Phase 2 study testing mycophenolate mofetil, antibody induction and Cyclosporine in people with Kidney Transplantation, run by Hoffmann-La Roche at 7 sites in Italy.
Trial summary
This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- mycophenolate mofetil, antibody induction and Cyclosporine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 7 sitesItaly
- Study dates
- Dec 2006to Sep 2008
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, 18 to 65 years of age
- Patients undergoing primary kidney transplantation
Who cannot join
- Recipients of multiple organ transplants
- Prior therapy with CellCept
- Presence or history of malignancies, except for successfully treated basal or squamous cell carcinoma of the skin
- Active peptic ulcer or active serious digestive system disease that may affect the absorption of CellCept
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Study site
Bari, 70124
Study site
Brescia, 25123
Study site
Coppito, 67100
Study site
Naples, 80131
Study site
Roma, 00168
Study site
Torino, 10126
Study site
Verona, 37126
About this study
Official title: Relationships Between Pharmacokinetic and Pharmacodynamic Strategies for Assessment of the Risks for Acute Rejection and Side Effects of Mycophenolate Mofetil
This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. All patients will receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24 weeks.
- Conditions
- Kidney Transplantation
- Being tested
- mycophenolate mofetil, antibody induction, Cyclosporine, corticosteroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called CellCept
1 g PO BID for 24 weeks
antibody inductionDrug
According to manufacturer recommendation
CyclosporineDrug
According to manufacturer recommendation
corticosteroidDrug
According to manufacturer recommendation
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate Mofetil Monotherapy | Experimental | Participants received an initial dose of mycophenolate mofetil (MMF), 1 gram (g), orally (PO), twice per day (BID), within 5 days of transplant for 24 weeks. Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. Receives: Drug: mycophenolate mofetil; Drug: antibody induction; Drug: Cyclosporine; Drug: corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Acute Rejection
Diagnosis of acute rejection was suspected in any participant with an increase in serum creatinine greater than or equal to (≥) 25 percent (%). All suspected acute rejections were confirmed by biopsy. The start date of acute rejection was identified as the date of biopsy.
Measured: Day 1, Weeks 2, 4, 12, 24, and 28
Time to Rejection
The mean time, in days, from the date of enrollment to date of biopsy confirming acute rejection.
Measured: Day 1, Weeks 2, 4, 12, 24, and 28
Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR)
BPAR was defined according to 1997 Banff Criteria as a biopsy Banff grade of IA, IB, IIA, IIB, or III. Grade IA was defined as significant interstitial infiltration with greater than (>)25% of parenchyma affected, and foci of moderate tubulitis with >4 mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IB was defined as significant interstitial infiltration with >25% parenchyma affected, and foci of severe tubulitis with >10% mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IIA was defined as mild to moderate intimal arteritis. Grade IIB was defined as severe intimal arteritis comprising >25% of the luminal area. Grade III was defined as transmural arteritis and/or arterial fibrinoid changes and necrosis of medial smooth muscle cells.
Measured: Day 1, Weeks 2, 4, 12, 24, and 28
Secondary outcomes (25)
Percentage of Participants With Graft Loss
An allograft was presumed to be lost if a participant started dialysis and was not able to subsequently be removed from dialysis.
Measured: Day 1, Weeks 2, 4, 12, 24, and 28
Percentage of Participants Surviving
Measured: Day 1, Weeks 2, 4, 12, 24, and 28
Total Mycophenolate Acid (MPA) by Visit and Timepoint
Drug quantification of total MPA (micrograms per milliliter [mcg/mL]) in the plasma was measured at time (T) = 0 minutes (min), 40 mins, and 120 mins.
Measured: Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up Visit), and any unscheduled visits
Free MPA (mcg/mL) by Visit
Drug quantification of free MPA in the plasma was measured at T = 0, 40, and 120 mins.
Measured: Weeks 2, 4, 12, 24, safety follow-up (Week 28), and any unscheduled visits
MPA Area Under the Concentration - Time Curve From Time 0 to 12 Hours (AUC0-12) (mcg/mL) by Visit
The AUC0-12 of MPA was estimated on the validated limited sampling strategy, AUC (milligrams multiplied by height over liter [mg.h/L]) = 7.182 + 4.607 multiplied by (*) concentration at 0 minutes (C0)+ 0.998 * the concentration at 40 minutes (C0.67) + 2.149 * the concentration at 120 minutes (C2).
Measured: Predose and 40 minutes and 2 hours postdose at Weeks 2, 4, 12, and 24, and at the Safety follow-up (Week 28)
Inosine MonoPhosphate DeHydrogenase (IMPDH) Activity by Visit and Timepoint
IMPDH activity in peripheral blood mononuclear cells (PBMCs) was measured at 2 timepoints per visit, 0 and 120 minutes and presented in enzyme units. The unit of measure of enzyme activity is "U". One U is defined as the amount of the enzyme that produces a certain amount of enzymatic activity that is, the amount that catalyzes the conversion of 1 micro mole of substrate per minute under pre-specified conditions (temperature, pH).
Measured: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
IMPDH Expression I by Visit and Timepoint
IMPDH I gene expression was measured by real time polymerase chain reaction (QRT-PCR) based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of messenger ribonucleic acid (mRNA) copies per cell (copies/cell).
Measured: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
IMPDH Expression II by Visit and Timepoint
IMPDH II gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.
Measured: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
Interleukin 8 (IL-8) Expression by Visit and Timepoint
IL-8 gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.
Measured: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
Tumor Necrosis Factor (TNF) Expression by Visit and Timepoint
TNF gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.
Measured: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
Percentage of Participants With Infection
Infections were graded according to the World Health Organization (WHO) worst grade observed.
Measured: BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)
Percentage of Participants With Gastrointestinal Toxicities
Gastrointestinal adverse events (AEs) according to WHO worst grade observed.
Measured: BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-up Visit)
Percentage of Participants With Hematologic Toxicity
Hematological toxicities graded according to WHO worst grade observed (Grade 1=mild, Grade 2=moderate).
Measured: BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)
Spearman's Rank Correlation Coefficient Between MPA Levels and IMPDH Activity
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
Measured: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH I Expression and MPA Levels
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
Measured: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH I Expression and Free Fraction
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
Measured: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH II Expression and MPA Levels
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
Measured: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH II Expression and Free Fraction
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
Measured: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH Inhibition and Risk of Acute Rejection
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
Measured: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Infection
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
Measured: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Hematologic Toxicity
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
Measured: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Gastrointestinal Toxicity
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
Measured: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Infection
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
Measured: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Hematologic Toxicity
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
Measured: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Gastrointestinal Toxicity
The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.
Measured: BL and Weeks 2, 4, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startDec 2006
- Primary completionSep 2008
- Study completionSep 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 Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292226
- Sponsor's protocol ID
- ML19835
- Status last verified
- Apr 2016
- First submitted
- 3 Feb 2011
- Last updated
- 12 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Between Pharmacokinetic and Pharmacodynamic Strategies for Assessment of the Risks for Acute Rejection and Side Effects of Mycophenolate Mofetil
- ClinicalTrials.gov ID
- NCT01292226
- Acronym / sponsor ID
- ML19835
- Conditions
- Kidney Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Posted 2 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. All patients will receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate Mofetil Monotherapy | Experimental | Drug: mycophenolate mofetil, Drug: antibody induction, Drug: Cyclosporine, Drug: corticosteroidParticipants received an initial dose of mycophenolate mofetil (MMF), 1 gram (g), orally (PO), twice per day (BID), within 5 days of transplant for 24 weeks. Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients, 18 to 65 years of age
- Patients undergoing primary kidney transplantation
Key exclusion criteria (4 listed)
- Recipients of multiple organ transplants
- Prior therapy with CellCept
- Presence or history of malignancies, except for successfully treated basal or squamous cell carcinoma of the skin
- Active peptic ulcer or active serious digestive system disease that may affect the absorption of CellCept
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 |
|---|---|---|
| mycophenolate mofetilAlso: CellCept1 g PO BID for 24 weeks | Drug | Mycophenolate Mofetil Monotherapy |
| antibody inductionAccording to manufacturer recommendation | Drug | Mycophenolate Mofetil Monotherapy |
| CyclosporineAccording to manufacturer recommendation | Drug | Mycophenolate Mofetil Monotherapy |
| corticosteroidAccording to manufacturer recommendation | Drug | Mycophenolate Mofetil Monotherapy |
Primary outcome
Percentage of Participants With Acute Rejection
Time frame: Day 1, Weeks 2, 4, 12, 24, and 28
Diagnosis of acute rejection was suspected in any participant with an increase in serum creatinine greater than or equal to (≥) 25 percent (%). All suspected acute rejections were confirmed by biopsy. The start date of acute rejection was identified as the date of biopsy.
Time to Rejection
Time frame: Day 1, Weeks 2, 4, 12, 24, and 28
The mean time, in days, from the date of enrollment to date of biopsy confirming acute rejection.
Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR)
Time frame: Day 1, Weeks 2, 4, 12, 24, and 28
BPAR was defined according to 1997 Banff Criteria as a biopsy Banff grade of IA, IB, IIA, IIB, or III. Grade IA was defined as significant interstitial infiltration with greater than (>)25% of parenchyma affected, and foci of moderate tubulitis with >4 mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IB was defined as significant interstitial infiltration with >25% parenchyma affected, and foci of severe tubulitis with >10% mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IIA was defined as mild to moderate intimal arteritis. Grade IIB was defined as severe intimal arteritis comprising >25% of the luminal area. Grade III was defined as transmural arteritis and/or arterial fibrinoid changes and necrosis of medial smooth muscle cells.
25 secondary outcomes
Percentage of Participants With Graft Loss
Time frame: Day 1, Weeks 2, 4, 12, 24, and 28
Percentage of Participants Surviving
Time frame: Day 1, Weeks 2, 4, 12, 24, and 28
Total Mycophenolate Acid (MPA) by Visit and Timepoint
Time frame: Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up Visit), and any unscheduled visits
Free MPA (mcg/mL) by Visit
Time frame: Weeks 2, 4, 12, 24, safety follow-up (Week 28), and any unscheduled visits
MPA Area Under the Concentration - Time Curve From Time 0 to 12 Hours (AUC0-12) (mcg/mL) by Visit
Time frame: Predose and 40 minutes and 2 hours postdose at Weeks 2, 4, 12, and 24, and at the Safety follow-up (Week 28)
Inosine MonoPhosphate DeHydrogenase (IMPDH) Activity by Visit and Timepoint
Time frame: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
IMPDH Expression I by Visit and Timepoint
Time frame: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
IMPDH Expression II by Visit and Timepoint
Time frame: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
Interleukin 8 (IL-8) Expression by Visit and Timepoint
Time frame: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
Tumor Necrosis Factor (TNF) Expression by Visit and Timepoint
Time frame: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
Percentage of Participants With Infection
Time frame: BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)
Percentage of Participants With Gastrointestinal Toxicities
Time frame: BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-up Visit)
Percentage of Participants With Hematologic Toxicity
Time frame: BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)
Spearman's Rank Correlation Coefficient Between MPA Levels and IMPDH Activity
Time frame: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH I Expression and MPA Levels
Time frame: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH I Expression and Free Fraction
Time frame: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH II Expression and MPA Levels
Time frame: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH II Expression and Free Fraction
Time frame: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH Inhibition and Risk of Acute Rejection
Time frame: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Infection
Time frame: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Hematologic Toxicity
Time frame: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Gastrointestinal Toxicity
Time frame: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Infection
Time frame: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Hematologic Toxicity
Time frame: BL and Weeks 2, 4, 12, and 24
Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Gastrointestinal Toxicity
Time frame: BL and Weeks 2, 4, 12, and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- 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.
Clinical Trials study chair
Hoffmann-La Roche
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mycophenolate mofetil, antibody induction and Cyclosporine in people with Kidney Transplantation, run by Hoffmann-La Roche at 7 sites in Italy.
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 4 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 2 Mar 2015). 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?
Percentage of Participants With Acute Rejection (time frame: Day 1, Weeks 2, 4, 12, 24, and 28). 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 12 May 2016.