Kidney Transplant Failure and RejectionPhase 4Cell220NCT00166712
A Trial of Two Steroid-Free Approaches Toward Mycophenolate Mofetil-Based Monotherapy Immunosuppression
A Phase 4 study testing Tacrolimus (TAC), Sirolimus and Alemtuzumab in people with Kidney Transplant Failure and Rejection, run by Northwestern University at 1 site in United States.
Trial summary
This is an open label, single-center, randomized phase IV pilot study of steroid and calcineurin inhibitor avoidance in renal transplant recipients. All patients will receive two doses of alemtuzumab to achieve peripheral T-cell depletion. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplant Failure and Rejection
- What is being tested?
- Tacrolimus (TAC), Sirolimus and Alemtuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Apr 2010
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are male or female age 18-65 years
- Donor age 18-65 years
- Patients who are single-organ recipients (kidney only)
- Women who are of childbearing potential must have a negative serum pregnancy test before transplantation and agree to use a medically acceptable method of contraception throughout the treatment period.
- Subject (recipient) is able to understand the consent form and give written informed consent
Who cannot join
- Known sensitivity or contraindication to sirolimus, tacrolimus or MMF
- Patient with significant or active infection
- Patients with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum
- Patients with PRA > 20%
- Patients who are pregnant or nursing mothers
- Patients whose life expectancy is severely limited by diseases other than renal disease
Show all 19Show fewer
- Ongoing active substance abuse, drug or alcohol
- Major ongoing psychiatric illness or recent history of noncompliance
- Significant cardiovascular disease (e.g.):
- Significant non-correctable coronary artery disease
- Ejection fraction below 30%
- History of recent myocardial infarction
- Malignancy within 3 years, excluding non-melanoma skin cancers
- Serologic evidence of infection with HIV or HBVsAg positive
- Patients with a screening/baseline total white blood cell count < 4,000/mm3; platelet count < 100,000/mm3; triglycerides > 400 mg/dl; total cholesterol > 300 mg/dl
- Investigational drug within 30 days prior to transplant surgery
- Anti-T cell therapy within 30 days prior to transplant surgery
- Patients using Prednisone
- Patients who are ABO incompatible
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University/Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: A Phase IV, Single Center Pilot Study Using Alemtuzumab (Campath-1H) Induction Combined With Prednisone-Free, Calcineurin-Inhibitor-Free Immunosuppression in Kidney Transplantation
This is an open label, single-center, randomized phase IV pilot study of steroid and calcineurin inhibitor avoidance in renal transplant recipients. All patients will receive two doses of alemtuzumab to achieve peripheral T-cell depletion. Intravenous glucocorticoids will be administered prior to alemtuzumab administration to limit cytokine release syndrome in association with this monoclonal antibody, and continued for the first two days post-transplant. Thereafter, steroids will not be used for immunosuppression. All transplant recipients will be started on oral immunosuppressive therapy with mycophenolate mofetil (MMF) prior to transplant. Pretransplant, these patients will be randomized to receive, in addition, either tacrolimus (Tac) or sirolimus.
After six months, patients in the tacrolimus arm who do not experience rejection will be randomized to continue on tacrolimus or to be converted to the combination of sirolimus and MMF. Individuals in this arm of the study who do not experience acute rejection, and demonstrate evidence of donor specific hyporesponsiveness at 9 months post-transplant (those staying on Tac + MMF) or 3 months post-conversion (those converted from Tac + MMF to sirolimus + MMF) will be weaned to MMF monotherapy.
Individuals in the sirolimus + MMF arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesponsiveness at 6 months post-transplant will be weaned to MMF monotherapy.
- Conditions
- Kidney Transplant Failure and Rejection
- Being tested
- Tacrolimus (TAC), Sirolimus, Alemtuzumab, Mycophenolate mofetil (MMF)
- Keywords
- Kidney Transplant, Living Donor Kidney Transplant Recipients
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus (TAC)Drug
Also called Prograf®, FK506
Tacrolimus (TAC) will be given standard of care by prescription twice a day (2.0 mg), orally. Doses will be adjusted by serum levels. The dose will be modified to achieve 12 hour trough concentrations of 5-8 ng/mL.
SirolimusDrug
Also called Rapamune®, Rapamycin
Sirolimus will be given standard of care by prescription, dosed at 5mg daily. The dosage will be adjusted by serum level to achieve 24 hour trough concentrations of 8-12 ng/mL by HPLC assay.
AlemtuzumabDrug
Also called Campath®, Campath-1H, Mabcampath®
Patients receiving alemtuzumab will be premedicated with 50mg of diphenhydramine hydrochloride, and 650mg of acetaminophen 30-60 minutes to the first Alemtuzumab infusion. The of 30mg will be diluted in 100cc sterile 0.9% normal saline and infused over 2 hours. The infusion line must contain an in-line 0.22-micron filter. Alemtuzumab will be administered on the day of transplant (intraoperatively), and on post-operative day 2. Both doses will be administered while the patient is in the hospital. Alemtuzumab is supplied in single-use clear glass ampoules containing 30mg of alemtuzumab in 3mL of solution.
Mycophenolate mofetil (MMF)Drug
Also called Cellcept®
MMF will be given at 1.0-1.5gm, twice daily, orally. The first dose will be given pre-transplant, open label fashion.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Alemtuzumab + TAC + MMF | Active comparator | Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily. Receives: Drug: Tacrolimus (TAC); Drug: Alemtuzumab; Drug: Mycophenolate mofetil (MMF) |
| Group 2: Alemtuzumab + Sirolimus + MMF | Active comparator | Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.
If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil. Receives: Drug: Sirolimus; Drug: Alemtuzumab; Drug: Mycophenolate mofetil (MMF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Biopsy-proven Acute Allograft Rejection During the First 12 Months of Transplant.
The incidence of rejection is determined by the proportion of patients experiencing biopsy proven acute allograft rejection during the first 12 months post-transplant.
Measured: Within 12 months post kidney transplant
Secondary outcomes (4)
Severity of Acute Rejection During the First 6 and 12 Months Post-transplant
The diagnosis of rejection will be based on clinical symptoms and signs, laboratory tests, and confirmed by core renal allograft biopsy.
Measured: Months 6-12 post-transplant
Renal Function at 12 Months Post-transplant
Laboratory tests for renal function include creatinine or iothalamate glomerular filtration rate (GFR).
Measured: At 12 months post-transplant
Incidence of Donor Specific Hyporesponsiveness Allowing for the Conversion to Monotherapy
The proportion of subjects for both groups determine this measure: 1) Patients in tacrolimus arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesonsiveness at 9 months post-transplant (those staying on TAC+MMF) or 3 months post-convertion (converted from TAC+MMF to Sirolimus+MMF) will be weaned to MMF monotherapy; 2) Those in the sirolimus+MMF arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesponsiveness at 6 months post-transplant will be weaned to MMF monotherapy.
Measured: At 6 & 9 months post-transplant
Patient and Graft Survival Rates at 6 and 12 Months Post-transplant
Measured: At 6 & 12 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Study stopped due to lack of efficacy \& funding.
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.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant Failure and RejectionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, Joseph Leventhal, Northwestern University
- Investigators
- Joseph R Leventhal, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166712
- Sponsor's protocol ID
- STU8789 0811-007
- Other IDs
- CNV0042139
- Acronym
- Cell220
- Status last verified
- Oct 2015
- First submitted
- 9 Sep 2005
- Last updated
- 26 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Eggers PW. Effect of transplantation on the Medicare end-stage renal disease program. N Engl J Med. 1988 Jan 28;318(4):223-9. doi: 10.1056/NEJM198801283180406.
PubMed 3275896Hariharan S, Johnson CP, Bresnahan BA, Taranto SE, McIntosh MJ, Stablein D. Improved graft survival after renal transplantation in the United States, 1988 to 1996. N Engl J Med. 2000 Mar 2;342(9):605-12. doi: 10.1056/NEJM200003023420901.
PubMed 10699159Barry JM. Immunosuppressive drugs in renal transplantation. A review of the regimens. Drugs. 1992 Oct;44(4):554-66. doi: 10.2165/00003495-199244040-00003.
PubMed 1281071Suthanthiran M, Strom TB. Renal transplantation. N Engl J Med. 1994 Aug 11;331(6):365-76. doi: 10.1056/NEJM199408113310606. No abstract available.
PubMed 7832839Helderman JH, Van Buren DH, Amend WJ Jr, Pirsch JD. Chronic immunosuppression of the renal transplant patient. J Am Soc Nephrol. 1994 Feb;4(8 Suppl):S2-9. doi: 10.1681/ASN.V48s2.
PubMed 8193291Gaston RS. Maintenance immunosuppression in the renal transplant recipient: an overview. Am J Kidney Dis. 2001 Dec;38(6 Suppl 6):S25-35. doi: 10.1053/ajkd.2001.28923.
PubMed 11729003Pirsch JD, D'Alessandro AM, Sollinger HW, Knechtle SJ, Reed A, Kalayoglu M, Belzer FO. Hyperlipidemia and transplantation: etiologic factors and therapy. J Am Soc Nephrol. 1992 Jun;2(12 Suppl):S238-42. doi: 10.1681/ASN.V212s238.
PubMed 1498281Shaw LM, Kaplan B, Kaufman D. Toxic effects of immunosuppressive drugs: mechanisms and strategies for controlling them. Clin Chem. 1996 Aug;42(8 Pt 2):1316-21.
PubMed 8697605Boubenider S, Hiesse C, Goupy C, Kriaa F, Marchand S, Charpentier B. Incidence and consequences of post-transplantation lymphoproliferative disorders. J Nephrol. 1997 May-Jun;10(3):136-45.
PubMed 9238621Fishman JA, Rubin RH. Infection in organ-transplant recipients. N Engl J Med. 1998 Jun 11;338(24):1741-51. doi: 10.1056/NEJM199806113382407. No abstract available.
PubMed 9624195DeMario MD, Liebowitz DN. Lymphomas in the immunocompromised patient. Semin Oncol. 1998 Aug;25(4):492-502.
PubMed 9728599Sia IG, Paya CV. Infectious complications following renal transplantation. Surg Clin North Am. 1998 Feb;78(1):95-112. doi: 10.1016/s0039-6109(05)70637-x.
PubMed 9531938Pirsch JD, Miller J, Deierhoi MH, Vincenti F, Filo RS. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation. FK506 Kidney Transplant Study Group. Transplantation. 1997 Apr 15;63(7):977-83. doi: 10.1097/00007890-199704150-00013.
PubMed 9112351Ahsan N, Hricik D, Matas A, Rose S, Tomlanovich S, Wilkinson A, Ewell M, McIntosh M, Stablein D, Hodge E. Prednisone withdrawal in kidney transplant recipients on cyclosporine and mycophenolate mofetil--a prospective randomized study. Steroid Withdrawal Study Group. Transplantation. 1999 Dec 27;68(12):1865-74. doi: 10.1097/00007890-199912270-00009.
PubMed 10628766Vincenti F, Ramos E, Brattstrom C, Cho S, Ekberg H, Grinyo J, Johnson R, Kuypers D, Stuart F, Khanna A, Navarro M, Nashan B. Multicenter trial exploring calcineurin inhibitors avoidance in renal transplantation. Transplantation. 2001 May 15;71(9):1282-7. doi: 10.1097/00007890-200105150-00017.
PubMed 11397963
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Single Center Pilot Study Using Alemtuzumab (Campath-1H) Induction Combined With Prednisone-Free, Calcineurin-Inhibitor-Free Immunosuppression in Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00166712
- Acronym / sponsor ID
- Cell220 / STU8789 0811-007
- Conditions
- Kidney Transplant Failure and Rejection
- Keywords
- Kidney Transplant, Living Donor Kidney Transplant Recipients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to lack of efficacy \& funding.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Apr 2005
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Posted 15 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, single-center, randomized phase IV pilot study of steroid and calcineurin inhibitor avoidance in renal transplant recipients. All patients will receive two doses of alemtuzumab to achieve peripheral T-cell depletion. Intravenous glucocorticoids will be administered prior to alemtuzumab administration to limit cytokine release syndrome in association with this monoclonal antibody, and continued for the first two days post-transplant. Thereafter, steroids will not be used for immunosuppression. All transplant recipients will be started on oral immunosuppressive therapy with mycophenolate mofetil (MMF) prior to transplant. Pretransplant, these patients will be randomized to receive, in addition, either tacrolimus (Tac) or sirolimus.
After six months, patients in the tacrolimus arm who do not experience rejection will be randomized to continue on tacrolimus or to be converted to the combination of sirolimus and MMF. Individuals in this arm of the study who do not experience acute rejection, and demonstrate evidence of donor specific hyporesponsiveness at 9 months post-transplant (those staying on Tac + MMF) or 3 months post-conversion (those converted from Tac + MMF to sirolimus + MMF) will be weaned to MMF monotherapy.
Individuals in the sirolimus + MMF arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesponsiveness at 6 months post-transplant will be weaned to MMF monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Alemtuzumab + TAC + MMF | Active comparator | Drug: Tacrolimus (TAC), Drug: Alemtuzumab, Drug: Mycophenolate mofetil (MMF)Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily. |
| Group 2: Alemtuzumab + Sirolimus + MMF | Active comparator | Drug: Sirolimus, Drug: Alemtuzumab, Drug: Mycophenolate mofetil (MMF)Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor. If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are male or female age 18-65 years
- Donor age 18-65 years
- Patients who are single-organ recipients (kidney only)
- Women who are of childbearing potential must have a negative serum pregnancy test before transplantation and agree to use a medically acceptable method of contraception throughout the treatment period.
- Subject (recipient) is able to understand the consent form and give written informed consent
Key exclusion criteria (19 listed)
- Known sensitivity or contraindication to sirolimus, tacrolimus or MMF
- Patient with significant or active infection
- Patients with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum
- Patients with PRA > 20%
- Patients who are pregnant or nursing mothers
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 |
|---|---|---|
| Tacrolimus (TAC)Also: Prograf®, FK506Tacrolimus (TAC) will be given standard of care by prescription twice a day (2.0 mg), orally. Doses will be adjusted by serum levels. The dose will be modified to achieve 12 hour trough concentrations of 5-8 ng/mL. | Drug | Group 1: Alemtuzumab + TAC + MMF |
| SirolimusAlso: Rapamune®, RapamycinSirolimus will be given standard of care by prescription, dosed at 5mg daily. The dosage will be adjusted by serum level to achieve 24 hour trough concentrations of 8-12 ng/mL by HPLC assay. | Drug | Group 2: Alemtuzumab + Sirolimus + MMF |
| AlemtuzumabAlso: Campath®, Campath-1H, Mabcampath®Patients receiving alemtuzumab will be premedicated with 50mg of diphenhydramine hydrochloride, and 650mg of acetaminophen 30-60 minutes to the first Alemtuzumab infusion. The of 30mg will be diluted in 100cc sterile 0.9% normal saline and infused over 2 hours. The infusion line must contain an in-line 0.22-micron filter. Alemtuzumab will be administered on the day of transplant (intraoperatively), and on post-operative day 2. Both doses will be administered while the patient is in the hospital. Alemtuzumab is supplied in single-use clear glass ampoules containing 30mg of alemtuzumab in 3mL of solution. | Drug | Group 1: Alemtuzumab + TAC + MMF, Group 2: Alemtuzumab + Sirolimus + MMF |
| Mycophenolate mofetil (MMF)Also: Cellcept®MMF will be given at 1.0-1.5gm, twice daily, orally. The first dose will be given pre-transplant, open label fashion. | Drug | Group 1: Alemtuzumab + TAC + MMF, Group 2: Alemtuzumab + Sirolimus + MMF |
Primary outcome
The Incidence of Biopsy-proven Acute Allograft Rejection During the First 12 Months of Transplant.
Time frame: Within 12 months post kidney transplant
The incidence of rejection is determined by the proportion of patients experiencing biopsy proven acute allograft rejection during the first 12 months post-transplant.
4 secondary outcomes
Severity of Acute Rejection During the First 6 and 12 Months Post-transplant
Time frame: Months 6-12 post-transplant
Renal Function at 12 Months Post-transplant
Time frame: At 12 months post-transplant
Incidence of Donor Specific Hyporesponsiveness Allowing for the Conversion to Monotherapy
Time frame: At 6 & 9 months post-transplant
Patient and Graft Survival Rates at 6 and 12 Months Post-transplant
Time frame: At 6 & 12 months post-transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3275896Eggers PW. Effect of transplantation on the Medicare end-stage renal disease program. N Engl J Med. 1988 Jan 28;318(4):223-9. doi: 10.1056/NEJM198801283180406.
- Background: PubMed 10699159Hariharan S, Johnson CP, Bresnahan BA, Taranto SE, McIntosh MJ, Stablein D. Improved graft survival after renal transplantation in the United States, 1988 to 1996. N Engl J Med. 2000 Mar 2;342(9):605-12. doi: 10.1056/NEJM200003023420901.
- Background: PubMed 1281071Barry JM. Immunosuppressive drugs in renal transplantation. A review of the regimens. Drugs. 1992 Oct;44(4):554-66. doi: 10.2165/00003495-199244040-00003.
- Background: PubMed 7832839Suthanthiran M, Strom TB. Renal transplantation. N Engl J Med. 1994 Aug 11;331(6):365-76. doi: 10.1056/NEJM199408113310606. No abstract available.
- Background: PubMed 8193291Helderman JH, Van Buren DH, Amend WJ Jr, Pirsch JD. Chronic immunosuppression of the renal transplant patient. J Am Soc Nephrol. 1994 Feb;4(8 Suppl):S2-9. doi: 10.1681/ASN.V48s2.
- Background: PubMed 11729003Gaston RS. Maintenance immunosuppression in the renal transplant recipient: an overview. Am J Kidney Dis. 2001 Dec;38(6 Suppl 6):S25-35. doi: 10.1053/ajkd.2001.28923.
- Background: PubMed 1498281Pirsch JD, D'Alessandro AM, Sollinger HW, Knechtle SJ, Reed A, Kalayoglu M, Belzer FO. Hyperlipidemia and transplantation: etiologic factors and therapy. J Am Soc Nephrol. 1992 Jun;2(12 Suppl):S238-42. doi: 10.1681/ASN.V212s238.
- Background: PubMed 8697605Shaw LM, Kaplan B, Kaufman D. Toxic effects of immunosuppressive drugs: mechanisms and strategies for controlling them. Clin Chem. 1996 Aug;42(8 Pt 2):1316-21.
- Background: PubMed 9238621Boubenider S, Hiesse C, Goupy C, Kriaa F, Marchand S, Charpentier B. Incidence and consequences of post-transplantation lymphoproliferative disorders. J Nephrol. 1997 May-Jun;10(3):136-45.
- Background: PubMed 9624195Fishman JA, Rubin RH. Infection in organ-transplant recipients. N Engl J Med. 1998 Jun 11;338(24):1741-51. doi: 10.1056/NEJM199806113382407. No abstract available.
- Background: PubMed 9728599DeMario MD, Liebowitz DN. Lymphomas in the immunocompromised patient. Semin Oncol. 1998 Aug;25(4):492-502.
- Background: PubMed 9531938Sia IG, Paya CV. Infectious complications following renal transplantation. Surg Clin North Am. 1998 Feb;78(1):95-112. doi: 10.1016/s0039-6109(05)70637-x.
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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.
Joseph R Leventhal, MD, PhD principal investigator
Northwestern University
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 Tacrolimus (TAC), Sirolimus and Alemtuzumab in people with Kidney Transplant Failure and Rejection, run by Northwestern University 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 5 inclusion and 19 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 26 Oct 2015. 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 15 Jan 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?
The Incidence of Biopsy-proven Acute Allograft Rejection During the First 12 Months of Transplant. (time frame: Within 12 months post kidney 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 NCT00166712, which also lists 24 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 26 Oct 2015.