Kidney TransplantationPhase 4ESP-CNINCT00912678
Minimizing Immunosuppression in Old for Old Kidney Transplantation
A Phase 4 study testing MMF (Cellcept) and Steroids and Tacrolimus (Prograf) in people with Kidney Transplantation, run by University of Luebeck at 5 sites in Germany.
Trial summary
Kidney transplantation in the elderly is a challenge since patient's co-morbidity and the decreased injury threshold of older grafts may limit the benefits of transplantation in these patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- MMF (Cellcept) and Steroids and Tacrolimus (Prograf)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesGermany
- Study dates
- Mar 2002to Oct 2008
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients receiving a cadaveric kidney transplant (first or re-transplant)
- Patients must met the criteria of the EUROTRANSPLANT program
- Organ allocation with the framework of EUROPEAN SENIOR PROGRAM (ESP) by EUROTRANSPLANT
- Written consent
Who cannot join
- Not fulfilled inclusion criteria
- Cadaveric kidney from "non heart beating donors"
- One or more than one steroid resistant acute rejections within the first 3 weeks after transplantation
- Two or more than two steroid sensitive rejections (more than 2 administered steroid boli) within the first 3 weeks after transplantation
- Tacrolimus trough level > 10ng/ml in three consecutive measurements
- Allergy against macrolide antibiotics or tacrolimus
Show all 11Show fewer
- Systemic steroid therapy at study entry not related to transplantation
- History of Malignancy
- Clinical relevant uncontrolled infections, heavy diarrhea, vomiting or active ulcer disease
- Patients who are enrolled in other clinical studies or were enrolled in other clinical studies 28 days before transplantation
- Patients under medication not approved by the German Ministry of Health
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Charite- Transplant Center - Campus Mitte
Berlin, State of Berlin, 10117
Charite - Transplant Center - Virchow Clinic
Berlin, State of Berlin, 13353
Transplant Center Cologne (Koeln-Mehrheim)
Cologne, Cologne, 51109
University of Essen - Transplant Center
Essen, Hesse
University of Luebeck, Transplant Center
Lübeck, 23562
About this study
Official title: Prospective Randomized Controlled Trial to Compare a Calcineurin Inhibitor Free Immunosuppression With a Low Dose Tacrolimus Based Immunosuppression in "Old for Old" Kidney Transplantation.
Kidney transplantation in the elderly is a challenge since patient's co-morbidity and the decreased injury threshold of older grafts may limit the benefits of transplantation in these patients. To compare favourable effects between low dose tacrolimus (LD-Tac) and mycophenolate-mofetil (MMF) in this patient population the investigators conducted a one year prospective multicenter randomized controlled trial. 90 kidney transplant recipients > 65 years with cadaveric grafts (> 65 years) from 5 centers were enrolled and received baseline immunosuppression with daclizumab induction (1 mg/kg) at day one and day 14, LD-Tac (trough level 5-8 µg/ml), MMF (1-2 g/d) and steroids. After three months, patients were centrally randomized either to MMF (1-2 g/d) and steroids (23 patients) or to LD-Tac and steroids. Follow-up visits were performed every 4 weeks up to one year. Protocol biopsies were performed after one year. The investigators' primary hypothesis is that the biopsy proven rejection rate in the MMF group is not significantly different compared to the LD-Tac group after one year. The investigators' secondary hypothesis is that graft function in the MMF group (reflected by the glomerular filtration rate and protocol biopsy result) is superior to the graft function in the LD-Tac group.
- Conditions
- Kidney Transplantation
- Being tested
- MMF (Cellcept) and Steroids, Tacrolimus (Prograf)
- Keywords
- Kidney transplantation, Old for old kidney transplantation, European senior program, Calcineurin inhibitor free immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMF (Cellcept) and SteroidsDrug
Also called Prograf, CellCept
Prograf was withdrawn completely after randomization, MMF and steroids were given.
Tacrolimus (Prograf)Drug
Also called Prograf
After randomization CellCept was withdrawn completely, low-dose tacrolimus was given.
| Study group | Role | What they receive |
|---|---|---|
| MMF and Steroid Group | Active comparator | Group of Patients randomized to MMF and Steroid maintenance immunosuppression after 3 months (Tacrolimus withdrawal) Receives: Drug: MMF (Cellcept) and Steroids |
| Low-Dose Tacrolimus Group | Active comparator | Patients randomized to withdrawal of MMF after 3 months and maintenance immunosuppression with low-dose tacrolimus and Steroids Receives: Drug: Tacrolimus (Prograf) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute rejection rate
Measured: One year
Secondary outcomes (1)
Graft function
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startMar 2002
- Primary completionJul 2006
- Study completionOct 2008
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 Kidney TransplantationStudies of the same condition, open and under way.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma GmbH
- Investigators
- Lutz Fricke, MD, PhD, Principal investigator, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912678
- Sponsor's protocol ID
- ESP-2004-1
- Acronym
- ESP-CNI
- Status last verified
- Jun 2009
- First submitted
- 1 Jun 2009
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vincenti F, Kirkman R, Light S, Bumgardner G, Pescovitz M, Halloran P, Neylan J, Wilkinson A, Ekberg H, Gaston R, Backman L, Burdick J. Interleukin-2-receptor blockade with daclizumab to prevent acute rejection in renal transplantation. Daclizumab Triple Therapy Study Group. N Engl J Med. 1998 Jan 15;338(3):161-5. doi: 10.1056/NEJM199801153380304.
PubMed 9428817Ducloux D, Motte G, Billerey C, Bresson-Vautrin C, Vautrin P, Rebibou JM, Saint-Hillier Y, Chalopin JM. Cyclosporin withdrawal with concomitant conversion from azathioprine to mycophenolate mofetil in renal transplant recipients with chronic allograft nephropathy: a 2-year follow-up. Transpl Int. 2002 Sep;15(8):387-92. doi: 10.1007/s00147-002-0403-3. Epub 2002 Aug 21.
PubMed 12221456Friemann S, Feuring E, Padberg W, Ernst W. Improvement of nephrotoxicity, hypertension, and lipid metabolism after conversion of kidney transplant recipients from cyclosporine to tacrolimus. Transplant Proc. 1998 Jun;30(4):1240-2. doi: 10.1016/s0041-1345(98)00226-7. No abstract available.
PubMed 9636504Pohanka E, Bechstein WO, Berlakovich G, Binet I, Friemann S, Heemann U, Kliem V, Sperschneider H, Stangl M, Ringe B. [Dosage and monitoring of tacrolimus after kidney transplantation]. Dtsch Med Wochenschr. 2000 May 12;125(19):608-11. No abstract available. German.
PubMed 11320722
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial to Compare a Calcineurin Inhibitor Free Immunosuppression With a Low Dose Tacrolimus Based Immunosuppression in "Old for Old" Kidney Transplantation.
- ClinicalTrials.gov ID
- NCT00912678
- Acronym / sponsor ID
- ESP-CNI / ESP-2004-1
- Conditions
- Kidney Transplantation
- Keywords
- Kidney transplantation, Old for old kidney transplantation, European senior program, Calcineurin inhibitor free immunosuppression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- Astellas Pharma GmbH
- Study start
- Mar 2002
- Primary completion
- Jul 2006 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 3 Jun 2009 (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.
Kidney transplantation in the elderly is a challenge since patient's co-morbidity and the decreased injury threshold of older grafts may limit the benefits of transplantation in these patients. To compare favourable effects between low dose tacrolimus (LD-Tac) and mycophenolate-mofetil (MMF) in this patient population the investigators conducted a one year prospective multicenter randomized controlled trial. 90 kidney transplant recipients > 65 years with cadaveric grafts (> 65 years) from 5 centers were enrolled and received baseline immunosuppression with daclizumab induction (1 mg/kg) at day one and day 14, LD-Tac (trough level 5-8 µg/ml), MMF (1-2 g/d) and steroids. After three months, patients were centrally randomized either to MMF (1-2 g/d) and steroids (23 patients) or to LD-Tac and steroids. Follow-up visits were performed every 4 weeks up to one year. Protocol biopsies were performed after one year. The investigators' primary hypothesis is that the biopsy proven rejection rate in the MMF group is not significantly different compared to the LD-Tac group after one year. The investigators' secondary hypothesis is that graft function in the MMF group (reflected by the glomerular filtration rate and protocol biopsy result) is superior to the graft function in the LD-Tac group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMF and Steroid Group | Active comparator | Drug: MMF (Cellcept) and SteroidsGroup of Patients randomized to MMF and Steroid maintenance immunosuppression after 3 months (Tacrolimus withdrawal) |
| Low-Dose Tacrolimus Group | Active comparator | Drug: Tacrolimus (Prograf)Patients randomized to withdrawal of MMF after 3 months and maintenance immunosuppression with low-dose tacrolimus and Steroids |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients receiving a cadaveric kidney transplant (first or re-transplant)
- Patients must met the criteria of the EUROTRANSPLANT program
- Organ allocation with the framework of EUROPEAN SENIOR PROGRAM (ESP) by EUROTRANSPLANT
- Written consent
Key exclusion criteria (11 listed)
- Not fulfilled inclusion criteria
- Cadaveric kidney from "non heart beating donors"
- One or more than one steroid resistant acute rejections within the first 3 weeks after transplantation
- Two or more than two steroid sensitive rejections (more than 2 administered steroid boli) within the first 3 weeks after transplantation
- Tacrolimus trough level > 10ng/ml in three consecutive measurements
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 |
|---|---|---|
| MMF (Cellcept) and SteroidsAlso: Prograf, CellCeptPrograf was withdrawn completely after randomization, MMF and steroids were given. | Drug | MMF and Steroid Group |
| Tacrolimus (Prograf)Also: PrografAfter randomization CellCept was withdrawn completely, low-dose tacrolimus was given. | Drug | Low-Dose Tacrolimus Group |
Primary outcome
Acute rejection rate
Time frame: One year
1 secondary outcome
Graft function
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2009.
- Background: PubMed 9428817Vincenti F, Kirkman R, Light S, Bumgardner G, Pescovitz M, Halloran P, Neylan J, Wilkinson A, Ekberg H, Gaston R, Backman L, Burdick J. Interleukin-2-receptor blockade with daclizumab to prevent acute rejection in renal transplantation. Daclizumab Triple Therapy Study Group. N Engl J Med. 1998 Jan 15;338(3):161-5. doi: 10.1056/NEJM199801153380304.
- Background: PubMed 12221456Ducloux D, Motte G, Billerey C, Bresson-Vautrin C, Vautrin P, Rebibou JM, Saint-Hillier Y, Chalopin JM. Cyclosporin withdrawal with concomitant conversion from azathioprine to mycophenolate mofetil in renal transplant recipients with chronic allograft nephropathy: a 2-year follow-up. Transpl Int. 2002 Sep;15(8):387-92. doi: 10.1007/s00147-002-0403-3. Epub 2002 Aug 21.
- Background: PubMed 9636504Friemann S, Feuring E, Padberg W, Ernst W. Improvement of nephrotoxicity, hypertension, and lipid metabolism after conversion of kidney transplant recipients from cyclosporine to tacrolimus. Transplant Proc. 1998 Jun;30(4):1240-2. doi: 10.1016/s0041-1345(98)00226-7. No abstract available.
- Background: PubMed 11320722Pohanka E, Bechstein WO, Berlakovich G, Binet I, Friemann S, Heemann U, Kliem V, Sperschneider H, Stangl M, Ringe B. [Dosage and monitoring of tacrolimus after kidney transplantation]. Dtsch Med Wochenschr. 2000 May 12;125(19):608-11. No abstract available. German.
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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.
Lutz Fricke, MD, PhD principal investigator
University of Luebeck
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MMF (Cellcept) and Steroids and Tacrolimus (Prograf) in people with Kidney Transplantation, run by University of Luebeck at 5 sites in Germany.
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 11 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 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute rejection rate (time frame: One year). 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 NCT00912678, 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 3 Jun 2009.