End-Stage Renal DiseasePhase 2NCT00023244
Steroid Withdrawal in Pediatric Kidney Transplant Recipients
A Phase 2 study testing Basiliximab, Cyclosporine and Tacrolimus in people with End-Stage Renal Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 sites in 2 countries.
Trial summary
The purpose of this study is to examine the effects of withdrawing steroids on graft rejection and kidney functions in kidney transplant recipients between the ages of 0 and 20 years (prior to their 21st birthday). Graft survival has improved in recent years in children with kidney transplants. Read more about this study
- Who is it for?
- Ages 1 day to 20 years
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- Basiliximab, Cyclosporine 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
- 274 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Jan 2001to Jun 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 1 day to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are between the ages of 0 and 20 years (prior to their 21st birthday)
- Are receiving their first living related (e.g.,kidney from a relative or unrelated donor) or cadaver donor transplant
- Are willing to practice an acceptable method of birth control during the study, if women able to have children
Who cannot join
- Patients will not be eligible for this study if they:
- Have received multiple organs
- Have received 2 or more transplants
- Have an active infection (including tuberculosis), or cancer
- Have used an experimental agent within 4 weeks of transplantation
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States18 sites
University of New Mexico Health Science Center
Albuquerque, New Mexico, 87131
Emory Children's Center
Atlanta, Georgia, 30322
Denver Children's Hospital
Aurora, Colorado, 80045
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Alabama
Birmingham, Alabama, 35233
Children's Hospital of Boston
Boston, Massachusetts, 02115
The Children's Hospital of Buffalo
Buffalo, New York, 14222
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Penn State College of Medicine
Hershey, Pennsylvania, 17033
University of Florida Health Science Center
Jacksonville, Florida, 32209
University of Wisconsin
Madison, Wisconsin, 53705
LeBonheur Children's Medical Center
Memphis, Tennessee, 38103
Tulane University Medical Center
New Orleans, Louisiana, 70112
Christopher Goldsbury Center
San Antonio, Texas, 78207
UCSD Medical Center
San Diego, California, 92103
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
Westchester Medical Center
Valhalla, New York, 10595
About this study
Official title: A Double-Blind Randomized Trial of Steroid Withdrawal in Sirolimus- and Cyclosporine-Treated Primary Transplant Recipients
The purpose of this study is to examine the effects of withdrawing steroids on graft rejection and kidney functions in kidney transplant recipients between the ages of 0 and 20 years (prior to their 21st birthday).
Graft survival has improved in recent years in children with kidney transplants. One bad side effect of steroid maintenance therapy has been growth retardation. Doctors believe steroids might be safely withdrawn in patients that are receiving other maintenance therapies. If steroids are removed, children might catch up in their growth and also might have fewer side effects of other kinds. This study evaluates whether steroid therapy can be withdrawn in a way that does not increase graft rejection.
Read the detailed description
Children receiving kidney (renal) transplantation face distressing issues in post-transplantation including but not limited to growth retardation directly attributable to corticosteroids (steroids). It is hypothesized that robust immunosuppression with sirolimus and calcineurin inhibitors (cyclosporine or tacrolimus) in conjunction with induction therapy should enable successful steroid withdrawal. A steroid-free environment could lessen side effects by enabling a child to achieve catch-up growth, reducing the need for anti-hypertensive therapy, and reducing the risk of cardiovascular disease. This trial tests the objective of providing a steroid-free state without incurring the risk of increased incidence of acute transplant rejections.
Patients are enrolled prior to kidney transplantation and receive standard evaluations. Patients receive induction therapy with basiliximab preoperatively and on Day 4 after surgery. Immunosuppressive therapy begins with sirolimus and either cyclosporine or tacrolimus on Day 1 following surgery, and with corticosteroids the day of surgery. Infection prophylaxis with Bactrim is begun on Day 1 after surgery and center-specific anti-cytomegalovirus (CMV) therapy is given for all recipients of a CMV positive kidney. At 6 months post-transplantation, all patients who have not had an episode of acute rejection undergo a renal graft biopsy. Patients who are confirmed to be free of subclinical rejection are randomized to either undergo complete steroid withdrawal or continue maintenance on daily steroids. Patients receive either steroids or placebo, while continuing other immunosuppressive medications. Patients are segregated into weight groups for steroid withdrawal that occurs over months 7 to 13. Any acute rejection event during withdrawal is confirmed by renal biopsy and managed with methylprednisolone treatment. Patients are followed for 3 years post-transplantation for analysis of growth rate, blood pressure, lipid profile and renal function as measured by serum creatinine and calculated creatinine clearances. Post-transplantation clinic visits are weekly for the first 2 months, every 2 weeks until 13 months, weekly during Month 13, every 2 weeks through Month 18, and monthly until the study ends.
Patients who exhibit evidence of acute or subclinical rejection do not continue the steroid withdrawal trial and care is managed by their pediatric renal transplant center physicians.
- Conditions
- End-Stage Renal Disease
- Being tested
- Basiliximab, Cyclosporine, Tacrolimus, Sirolimus, Methylprednisolone
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BasiliximabDrug
Also called Simulect, Anti-CD25 monoclonal antibody, chimeric
Administered as a bolus intravenous injection. The first dose is given pre-operatively, the second dose is given on post-transplant day four. Dosage is determined by individual weight.
CyclosporineDrug
Also called CsA
Participants receiving cyclosporine microemulsion formula (in lieu of tacrolimus) will have the dose adjusted to maintain a whole blood trough Abbott TDx assay monoclonal level of 175-400 ng/mL (or an equivalent high pressure liquid chromatography (HPLC) level) for the first 2 weeks after transplant. The dose will subsequently be tapered to maintain a trough level of 175-300 ng/mL from week 3 to month 3, and 50-250 ng/mL from month 3 through the end of the study at month 36 (year 3).
TacrolimusDrug
Participants receiving tacrolimus (in lieu of Cyclosporine) will have the dose adjusted to maintain a whole blood trough level between 10 and 15 ng/mL for the first 4weeks after transplant. Trough levels will be maintained between 5 and 10 ng/mL thereafter throughout the duration of the study.
SirolimusDrug
Participants take daily (orally, either as tablets or as liquid) starting on postoperative day 1 at a dose of 6 mg/m2 and will be adjusted to maintain a trough level of 10-20 ng/mL throughout the study.
Administered at 10 mg/kg intravenously perioperatively and on postoperative day 1.
PrednisoneDrug
Administered orally beginning on Post-Op Day 2 and maintained for all participants until day 180. Randomization will determine whether patients will maintain this treatment following day 180.
BactrimDrug
Also called TMP SMX, trimethoprim/sulfamethoxazole
All subjects will receive TMP SMX (Bactrim), pneumocystis jiroveci (carinii) prophylaxis, beginning on postoperative day 1 and continuing for 6 months following transplant. Dosage: 10 mg/kg taken orally three times weekly (maximum dose 160 mg).
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid (steroid) withdrawal | Experimental | All enrolled subjects who have not experienced an episode of acute rejection or other event resulting in removal from the study in the first 6 months after transplantation will undergo a protocol-driven biopsy at 6 months. Subjects with no clinical or histologic evidence of rejection will be eligible to be randomized and treated in a double-blinded (e.g., masked-neither subject nor health care providers will know treatment being received) fashion while continuing other immunosuppressive medications. Subjects in this arm will undergo complete steroid withdrawal by the end of 12 months post-transplant. Receives: Drug: Basiliximab; Drug: Cyclosporine; Drug: Tacrolimus; Drug: Sirolimus; Drug: Methylprednisolone; Drug: Prednisone; Drug: Bactrim |
| Control Treatment | Active comparator | All enrolled subjects who have not experienced an episode of acute rejection or other event resulting in removal from the study in the first 6 months after transplantation will undergo a protocol-driven biopsy at 6 months. Subjects with no clinical or histologic evidence of rejection will be eligible to be randomized and treated in a double-blinded (e.g., masked-neither subject nor health care providers will know treatment being received) fashion while continuing other immunosuppressive medications. Subjects in this arm will be maintained on low-dose (0.15 mg/kg/day) daily steroids. Receives: Drug: Basiliximab; Drug: Cyclosporine; Drug: Tacrolimus; Drug: Sirolimus; Drug: Methylprednisolone; Drug: Prednisone; Drug: Bactrim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth, measured as change in standardized height from 6 month to 2.5 years post-transplantation
Measured: At 6 months and 2.5 years post-transplant
Secondary outcomes (7)
Graft and patient survival
Measured: Throughout study
Biopsy-proven acute rejection
Measured: Throughout study
Renal function, measured by serum creatinine and the calculated creatinine clearances
Measured: Throughout study
Hypertension
Measured: Throughout study
Cushingoid features
Measured: Throughout study
Systolic and diastolic blood pressure levels
Measured: Throughout study
Fasting lipid profile
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startJan 2001
- Primary completionJun 2005
- Study completionJun 2005
Why it stopped: Effective August 13, 2004: Unanticipated high incidence of post-transplant lymphoproliferative disorder
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Cooperative Clinical Trials in Pediatric Transplantation
- Responsible party
- Sponsor
- Investigators
- William Harmon, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023244
- Sponsor's protocol ID
- DAIT SW01
- Status last verified
- Oct 2016
- First submitted
- 29 Aug 2001
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Publications
Magee JC. Steroids in pediatric kidney transplantation: a balancing act in progress. Am J Transplant. 2010 Jan;10(1):6-7. doi: 10.1111/j.1600-6143.2009.02923.x. Epub 2009 Dec 17. No abstract available.
PubMed 19958331Li L, Chang A, Naesens M, Kambham N, Waskerwitz J, Martin J, Wong C, Alexander S, Grimm P, Concepcion W, Salvatierra O, Sarwal MM. Steroid-free immunosuppression since 1999: 129 pediatric renal transplants with sustained graft and patient benefits. Am J Transplant. 2009 Jun;9(6):1362-72. doi: 10.1111/j.1600-6143.2009.02640.x. Epub 2009 May 13.
PubMed 19459814Benfield MR, Bartosh S, Ikle D, Warshaw B, Bridges N, Morrison Y, Harmon W. A randomized double-blind, placebo controlled trial of steroid withdrawal after pediatric renal transplantation. Am J Transplant. 2010 Jan;10(1):81-8. doi: 10.1111/j.1600-6143.2009.02767.x. Epub 2009 Jul 28.
PubMed 19663893McDonald RA, Smith JM, Ho M, Lindblad R, Ikle D, Grimm P, Wyatt R, Arar M, Liereman D, Bridges N, Harmon W; CCTPT Study Group. Incidence of PTLD in pediatric renal transplant recipients receiving basiliximab, calcineurin inhibitor, sirolimus and steroids. Am J Transplant. 2008 May;8(5):984-9. doi: 10.1111/j.1600-6143.2008.02167.x.
PubMed 18416737
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Randomized Trial of Steroid Withdrawal in Sirolimus- and Cyclosporine-Treated Primary Transplant Recipients
- ClinicalTrials.gov ID
- NCT00023244
- Acronym / sponsor ID
- DAIT SW01
- Conditions
- End-Stage Renal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Effective August 13, 2004: Unanticipated high incidence of post-transplant lymphoproliferative disorder
- Enrolment
- 274 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Cooperative Clinical Trials in Pediatric Transplantation
- Study start
- Jan 2001
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
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 this study is to examine the effects of withdrawing steroids on graft rejection and kidney functions in kidney transplant recipients between the ages of 0 and 20 years (prior to their 21st birthday).
Graft survival has improved in recent years in children with kidney transplants. One bad side effect of steroid maintenance therapy has been growth retardation. Doctors believe steroids might be safely withdrawn in patients that are receiving other maintenance therapies. If steroids are removed, children might catch up in their growth and also might have fewer side effects of other kinds. This study evaluates whether steroid therapy can be withdrawn in a way that does not increase graft rejection.
Detailed description
Children receiving kidney (renal) transplantation face distressing issues in post-transplantation including but not limited to growth retardation directly attributable to corticosteroids (steroids). It is hypothesized that robust immunosuppression with sirolimus and calcineurin inhibitors (cyclosporine or tacrolimus) in conjunction with induction therapy should enable successful steroid withdrawal. A steroid-free environment could lessen side effects by enabling a child to achieve catch-up growth, reducing the need for anti-hypertensive therapy, and reducing the risk of cardiovascular disease. This trial tests the objective of providing a steroid-free state without incurring the risk of increased incidence of acute transplant rejections.
Patients are enrolled prior to kidney transplantation and receive standard evaluations. Patients receive induction therapy with basiliximab preoperatively and on Day 4 after surgery. Immunosuppressive therapy begins with sirolimus and either cyclosporine or tacrolimus on Day 1 following surgery, and with corticosteroids the day of surgery. Infection prophylaxis with Bactrim is begun on Day 1 after surgery and center-specific anti-cytomegalovirus (CMV) therapy is given for all recipients of a CMV positive kidney. At 6 months post-transplantation, all patients who have not had an episode of acute rejection undergo a renal graft biopsy. Patients who are confirmed to be free of subclinical rejection are randomized to either undergo complete steroid withdrawal or continue maintenance on daily steroids. Patients receive either steroids or placebo, while continuing other immunosuppressive medications. Patients are segregated into weight groups for steroid withdrawal that occurs over months 7 to 13. Any acute rejection event during withdrawal is confirmed by renal biopsy and managed with methylprednisolone treatment. Patients are followed for 3 years post-transplantation for analysis of growth rate, blood pressure, lipid profile and renal function as measured by serum creatinine and calculated creatinine clearances. Post-transplantation clinic visits are weekly for the first 2 months, every 2 weeks until 13 months, weekly during Month 13, every 2 weeks through Month 18, and monthly until the study ends.
Patients who exhibit evidence of acute or subclinical rejection do not continue the steroid withdrawal trial and care is managed by their pediatric renal transplant center physicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid (steroid) withdrawal | Experimental | Drug: Basiliximab, Drug: Cyclosporine, Drug: Tacrolimus, Drug: Sirolimus, Drug: Methylprednisolone, Drug: Prednisone, Drug: BactrimAll enrolled subjects who have not experienced an episode of acute rejection or other event resulting in removal from the study in the first 6 months after transplantation will undergo a protocol-driven biopsy at 6 months. Subjects with no clinical or histologic evidence of rejection will be eligible to be randomized and treated in a double-blinded (e.g., masked-neither subject nor health care providers will know treatment being received) fashion while continuing other immunosuppressive medications. Subjects in this arm will undergo complete steroid withdrawal by the end of 12 months post-transplant. |
| Control Treatment | Active comparator | Drug: Basiliximab, Drug: Cyclosporine, Drug: Tacrolimus, Drug: Sirolimus, Drug: Methylprednisolone, Drug: Prednisone, Drug: BactrimAll enrolled subjects who have not experienced an episode of acute rejection or other event resulting in removal from the study in the first 6 months after transplantation will undergo a protocol-driven biopsy at 6 months. Subjects with no clinical or histologic evidence of rejection will be eligible to be randomized and treated in a double-blinded (e.g., masked-neither subject nor health care providers will know treatment being received) fashion while continuing other immunosuppressive medications. Subjects in this arm will be maintained on low-dose (0.15 mg/kg/day) daily steroids. |
Who may qualify
- Ages
- 1 day to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Are between the ages of 0 and 20 years (prior to their 21st birthday)
- Are receiving their first living related (e.g.,kidney from a relative or unrelated donor) or cadaver donor transplant
- Are willing to practice an acceptable method of birth control during the study, if women able to have children
Key exclusion criteria (5 listed)
- Have received multiple organs
- Have received 2 or more transplants
- Have an active infection (including tuberculosis), or cancer
- Have used an experimental agent within 4 weeks of transplantation
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 |
|---|---|---|
| BasiliximabAlso: Simulect, Anti-CD25 monoclonal antibody, chimericAdministered as a bolus intravenous injection. The first dose is given pre-operatively, the second dose is given on post-transplant day four. Dosage is determined by individual weight. | Drug | Control Treatment, Corticosteroid (steroid) withdrawal |
| CyclosporineAlso: CsAParticipants receiving cyclosporine microemulsion formula (in lieu of tacrolimus) will have the dose adjusted to maintain a whole blood trough Abbott TDx assay monoclonal level of 175-400 ng/mL (or an equivalent high pressure liquid chromatography (HPLC) level) for the first 2 weeks after transplant. The dose will subsequently be tapered to maintain a trough level of 175-300 ng/mL from week 3 to month 3, and 50-250 ng/mL from month 3 through the end of the study at month 36 (year 3). | Drug | Control Treatment, Corticosteroid (steroid) withdrawal |
| TacrolimusParticipants receiving tacrolimus (in lieu of Cyclosporine) will have the dose adjusted to maintain a whole blood trough level between 10 and 15 ng/mL for the first 4weeks after transplant. Trough levels will be maintained between 5 and 10 ng/mL thereafter throughout the duration of the study. | Drug | Control Treatment, Corticosteroid (steroid) withdrawal |
| SirolimusParticipants take daily (orally, either as tablets or as liquid) starting on postoperative day 1 at a dose of 6 mg/m2 and will be adjusted to maintain a trough level of 10-20 ng/mL throughout the study. | Drug | Control Treatment, Corticosteroid (steroid) withdrawal |
| MethylprednisoloneAdministered at 10 mg/kg intravenously perioperatively and on postoperative day 1. | Drug | Control Treatment, Corticosteroid (steroid) withdrawal |
| PrednisoneAdministered orally beginning on Post-Op Day 2 and maintained for all participants until day 180. Randomization will determine whether patients will maintain this treatment following day 180. | Drug | Control Treatment, Corticosteroid (steroid) withdrawal |
| BactrimAlso: TMP SMX, trimethoprim/sulfamethoxazoleAll subjects will receive TMP SMX (Bactrim), pneumocystis jiroveci (carinii) prophylaxis, beginning on postoperative day 1 and continuing for 6 months following transplant. Dosage: 10 mg/kg taken orally three times weekly (maximum dose 160 mg). | Drug | Control Treatment, Corticosteroid (steroid) withdrawal |
Primary outcome
Growth, measured as change in standardized height from 6 month to 2.5 years post-transplantation
Time frame: At 6 months and 2.5 years post-transplant
7 secondary outcomes
Graft and patient survival
Time frame: Throughout study
Biopsy-proven acute rejection
Time frame: Throughout study
Renal function, measured by serum creatinine and the calculated creatinine clearances
Time frame: Throughout study
Hypertension
Time frame: Throughout study
Cushingoid features
Time frame: Throughout study
Systolic and diastolic blood pressure levels
Time frame: Throughout study
Fasting lipid profile
Time frame: Throughout study
Results and safety
The study was stopped early (reason given: Effective August 13, 2004: Unanticipated high incidence of post-transplant lymphoproliferative disorder). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Background: PubMed 19958331Magee JC. Steroids in pediatric kidney transplantation: a balancing act in progress. Am J Transplant. 2010 Jan;10(1):6-7. doi: 10.1111/j.1600-6143.2009.02923.x. Epub 2009 Dec 17. No abstract available.
- Background: PubMed 19459814Li L, Chang A, Naesens M, Kambham N, Waskerwitz J, Martin J, Wong C, Alexander S, Grimm P, Concepcion W, Salvatierra O, Sarwal MM. Steroid-free immunosuppression since 1999: 129 pediatric renal transplants with sustained graft and patient benefits. Am J Transplant. 2009 Jun;9(6):1362-72. doi: 10.1111/j.1600-6143.2009.02640.x. Epub 2009 May 13.
- Results publication: PubMed 19663893Benfield MR, Bartosh S, Ikle D, Warshaw B, Bridges N, Morrison Y, Harmon W. A randomized double-blind, placebo controlled trial of steroid withdrawal after pediatric renal transplantation. Am J Transplant. 2010 Jan;10(1):81-8. doi: 10.1111/j.1600-6143.2009.02767.x. Epub 2009 Jul 28.
- Results publication: PubMed 18416737McDonald RA, Smith JM, Ho M, Lindblad R, Ikle D, Grimm P, Wyatt R, Arar M, Liereman D, Bridges N, Harmon W; CCTPT Study Group. Incidence of PTLD in pediatric renal transplant recipients receiving basiliximab, calcineurin inhibitor, sirolimus and steroids. Am J Transplant. 2008 May;8(5):984-9. doi: 10.1111/j.1600-6143.2008.02167.x.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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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.
William Harmon, MD principal investigator
Boston Children's Hospital
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Basiliximab, Cyclosporine and Tacrolimus in people with End-Stage Renal Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 sites in 2 countries.
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 4 inclusion and 5 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Mexico. 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?
The study was stopped early (reason given: Effective August 13, 2004: Unanticipated high incidence of post-transplant lymphoproliferative disorder). Results are not available in the source record.
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?
Growth, measured as change in standardized height from 6 month to 2.5 years post-transplantation (time frame: At 6 months and 2.5 years post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00023244, which also lists 4 linked publications.
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 21 Oct 2016.