Diabetes Mellitus, Adult-OnsetPhase 401-DMPTNCT01002339
Optimum Immunosuppression in Renal Transplant Recipients.New Onset Diabetes After Transplantation
A Phase 4 study testing Tacrolimus with rapid steroid withdrawal, Tacrolimus with steroids minimization and CsA with steroid minimization in people with Diabetes Mellitus, Adult-Onset, run by Armando Torres Ramírez at 10 sites in Spain.
Trial summary
New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. Cyclosporine (CsA) and Tacrolimus are the basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection and graft function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Adult-Onset
- What is being tested?
- Tacrolimus with rapid steroid withdrawal, Tacrolimus with steroids minimization and CsA with steroid minimization
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 10 sitesSpain
- Study dates
- Feb 2010to Jun 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary renal transplant recipients with end stage renal disease
- No prior history of diabetes mellitus before transplant
- Absence of Immunologic risk defined by the investigator criterion and Panel Reactive Antibody (PRA) < 50%
- Absence of severe infection and hepatitis C or B infection
- Efficient contraception in women during the study
- Additionally must meet one of these "Metabolic Criteria
- Recipient age >or =60 or
- Recipient age between 45 and 59 years and at least one of the following metabolic criteria: Prior to transplantation Triglycerides (TGS) >200mg/dl or the combination of a body mass index (BMI)> 27 and Triglycerides>150 mg/dl or the combination of HDL-cholesterol<40 mg/dl for men or <50 mg/dl for women and Triglycerides >150 mg/dl.
Who cannot join
- Patients with type I or II diabetes prior to transplantation defined by the American Diabetes Association (ADA) criteria
- Recipient age under 45
- Patients receiving a second renal transplant
- Patients with high immunological risk or PRA (panel reactive antibody level) >or =50%
- Severe infection or hepatitis C or B infection.
- Dual renal transplant or double transplant with any other organ.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Francisco Valdés
A Coruña, Galicia, 15006
Juan Manuel Díaz
Barcelona, Catalonia, 08025
Francisco Moreso
Barcelona, Catalonia, 08035
Antonio Osuna
Granada, Andalusia, 18014
Roberto Gallego
Las Palmas de Gran Canaria, 35010
Domingo Hernández
Málaga, Andalusia, 29010
Carmen Díaz Corte
Oviedo, Principality of Asturias, 33006
Armando Torres Ramírez
San Cristóbal de La Laguna, S/C de Tenerife, 38320
Carlos Gómez Alamillo
Santander, Cantabria, 39008
Luis Pallardo
Valencia, 46017
About this study
Official title: Optimum Immunosuppression in Renal Transplant Recipients at High Risk of Developing New Onset Diabetes After Transplantation: A Multicenter, Prospective, Controlled and Randomized Trial.
New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. Cyclosporine (CsA) and Tacrolimus are the basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection and graft function. However, Tacrolimus increases 2 times the risk of NODAT as compared to CsA.
Read the detailed description
New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. CsA and Tacrolimus are the basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection and graft function. However, increases 2 times the risk of NODAT as compared to CsA. Objectives: a) To compare the incidence of NODAT and glucose intolerance with 3 different regimes: Tacrolimus with rapid steroid withdrawal; Tacrolimus with steroids minimization; and CsA with steroid minimization; b) To compare acute rejection rate, renal function and graft and patient survival between different regimes; and c) to investigate the influence of different regimes on subclinical atheromatosis. A total of 210 patients will be randomized. The primary efficacy variable will be NODAT or glucose intolerance at 1 year; secondary efficacy variables will be acute rejection, renal function, and changes of carotid intima-media thickness over time.
- Conditions
- Diabetes Mellitus, Adult-Onset
- Being tested
- Tacrolimus with rapid steroid withdrawal, Tacrolimus with steroids minimization, CsA with steroid minimization
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus with rapid steroid withdrawalDrug
Also called Simulect; Dacortin; Prograf/Advagraf; Cellcept/Myfortic.
- Basiliximab induction (4 mg i.v., days 0 and 4).
- Corticosteroids: 0.5 gr of i.v. Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7.
- Tacrolimus: 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month and then 5-8 ng/ml.
- Mycophenolate mofetil 1 gr b.i.d. for the first month and then 500 mg b.i.d.
Tacrolimus with steroids minimizationDrug
Also called Simulect; Dacortin; Prograf/Advagraf; Cellcept/Myfortic.
- Basiliximab induction (4 mg i.v., days 0 an 4)
- Corticosteroids: 0.5 gr of i.v. MP intraoperatively and 60 mg on the first day, followed by oral doses of prednisone starting with 0.3 mg/Kg/day, and gradual weekly tapering to complete discontinuation over 6 months.
- Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month and then 5-8 ng/ml.
- Mycophenolate mofetil 1 gr b.i.d. for the first month and then 500 mg b.i.d.
CsA with steroid minimizationDrug
Also called Simulect; Dacortin; Sandimmun Neoral; Cellcept/Myfortic.
- Basiliximab induction (4 mg i.v., days 0 an 4)
- Corticosteroids: 0.5 gr of i.v. MP intraoperatively and 60 mg on the first day, followed by oral doses of prednisone starting with 0.3 mg/Kg/day, and gradual weekly tapering to complete discontinuation over 6 months.
- CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month and then 100-150 ng/ml.
- Mycophenolate mofetil 1 gr b.i.d
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus with rapid steroid withdrawal | Experimental | Basiliximab induction. Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week. Receives: Drug: Tacrolimus with rapid steroid withdrawal |
| Tacrolimus with steroids minimization | Active comparator | Basiliximab induction.Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal Receives: Drug: Tacrolimus with steroids minimization |
| CsA with steroid minimization | Experimental | Basiliximab induction. Ciclosporin A (CsA) plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal Receives: Drug: CsA with steroid minimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure "New Onset Diabetes After Renal Transplantation" (NODAT)
American Diabetes Association criteria (ADA) including an oral glucose tolerance test.
Measured: 1 year
Patients Treated With Insulin or Oral Antidiabetic Drugs
Measured: 1 year
Primary Outcome Measure (Glucose Intolerance)
Glycemia >=140 and <200 mg/dl, 2 hours after a standard oral glucose tolerance test. Measured values: glucose intolerance at 1 year defined by ADA criteria.
Measured: 1 year
Secondary outcomes (13)
Rejection
Biopsy proven acute rejection. Measured variable: Rate of Biopsy proven acute rejection.
Measured: 1 year
Renal Function
Estimated Glomerular Filtration Rate (ml/min/1.73 m^2)
Measured: 1 year
Proteinuria
Measured: 1 year
Blood Pressure
Systolic pressure (mmHg)
Measured: 1 year
Blood Pressure
Diastolic pressure (mmHg)
Measured: 1 year
Number of Antihypertensive Drugs Patients Reported Taking.
Measured: 1 year
Lipidic Profile (Triglycerides)
Measured: 1 year
Lipidic Profile (Cholesterol)
Lipidic Profile (total cholesterol)
Measured: 1 year
Lipidic Profile (HDL-c)
Measured: 1 year
Lipidic Profile (LDL-c)
Measured: 1 year
Percentage of Patients Using Statins
Measured: 1 year
Changes of Carotid Intima-media Thickness Over Time
absolute difference between carotid intima-media thickness at study end versus baseline.
Measured: 1 year
Percentage of Patients Using Acetylsalicylic Acid (ASA)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startFeb 2010
- Primary completionFeb 2014
- Study completionJun 2015
Why it stopped: Terminated: higher rate of acute rejection in the Cyclosporin A group
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 (11)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Adult-OnsetStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armando Torres Ramírez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Armando Torres Ramírez, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
- Investigators
- Armando Torres, PhD, Study director, Fundación Canaria para la Investigación Biomédica Rafael Clavijo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002339
- Sponsor's protocol ID
- FundacionRC
- Acronym
- 01-DMPT
- Status last verified
- Sep 2024
- First submitted
- 26 Oct 2009
- Last updated
- 22 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Porrini E, Gomez MD, Alvarez A, Cobo M, Gonzalez-Posada JM, Perez L, Hortal L, Garcia JJ, Dolores Checa M, Morales A, Hernandez D, Torres A. Glycated haemoglobin levels are related to chronic subclinical inflammation in renal transplant recipients without pre-existing or new onset diabetes. Nephrol Dial Transplant. 2007 Jul;22(7):1994-9. doi: 10.1093/ndt/gfm067. Epub 2007 Mar 29.
PubMed 17395658Alvarez A, Fernandez J, Porrini E, Delgado P, Pitti S, Vega MJ, Gonzalez-Posada JM, Rodriguez A, Perez L, Marrero D, Luis D, Velazquez S, Hernandez D, Salido E, Torres A. Carotid atheromatosis in nondiabetic renal transplant recipients: the role of prediabetic glucose homeostasis alterations. Transplantation. 2007 Oct 15;84(7):870-5. doi: 10.1097/01.tp.0000284462.70064.ae.
PubMed 17984840Hernandez D, Miquel R, Porrini E, Fernandez A, Gonzalez-Posada JM, Hortal L, Checa MD, Rodriguez A, Garcia JJ, Rufino M, Torres A. Randomized controlled study comparing reduced calcineurin inhibitors exposure versus standard cyclosporine-based immunosuppression. Transplantation. 2007 Sep 27;84(6):706-14. doi: 10.1097/01.tp.0000282872.17024.b7.
PubMed 17893603Porrini E, Delgado P, Alvarez A, Cobo M, Perez L, Gonzalez-Posada JM, Hortal L, Gallego R, Garcia JJ, Checa M, Morales A, Salido E, Hernandez D, Torres A. The combined effect of pre-transplant triglyceride levels and the type of calcineurin inhibitor in predicting the risk of new onset diabetes after renal transplantation. Nephrol Dial Transplant. 2008 Apr;23(4):1436-41. doi: 10.1093/ndt/gfm762. Epub 2007 Nov 19.
PubMed 18029372Porrini E, Moreno JM, Osuna A, Benitez R, Lampreabe I, Diaz JM, Silva I, Dominguez R, Gonzalez-Cotorruelo J, Bayes B, Lauzurica R, Ibernon M, Moreso F, Delgado P, Torres A. Prediabetes in patients receiving tacrolimus in the first year after kidney transplantation: a prospective and multicenter study. Transplantation. 2008 Apr 27;85(8):1133-8. doi: 10.1097/TP.0b013e31816b16bd.
PubMed 18431233Bayes B, Moreso F, Benitez R, Torres A, Diaz JM, Granada ML, Lauzurica R, Pastor MC, Teixido J. [Post-transplant diabetes mellitus depending on the pre-transplant dialysis technique]. Nefrologia. 2008;28 Suppl 6:97-102. Spanish.
PubMed 18957019Porrini E, Bayes B, Diaz JM, Ibernon M, Benitez R, Dominguez R, Moreno JM, Delgado P, Lauzurica R, Silva I, Moreso F, Lampreabe I, Arias M, Osuna A, Torres A. Hyperinsulinemia and hyperfiltration in renal transplantation. Transplantation. 2009 Jan 27;87(2):274-9. doi: 10.1097/TP.0b013e318191a7d5.
PubMed 19155984Porrini EL, Diaz JM, Moreso F, Delgado Mallen PI, Silva Torres I, Ibernon M, Bayes-Genis B, Benitez-Ruiz R, Lampreabe I, Lauzurrica R, Osorio JM, Osuna A, Dominguez-Rollan R, Ruiz JC, Jimenez-Sosa A, Gonzalez-Rinne A, Marrero-Miranda D, Macia M, Garcia J, Torres A. Clinical evolution of post-transplant diabetes mellitus. Nephrol Dial Transplant. 2016 Mar;31(3):495-505. doi: 10.1093/ndt/gfv368. Epub 2015 Nov 3.
PubMed 26538615Rodriguez-Rodriguez AE, Trinanes J, Porrini E, Velazquez-Garcia S, Fumero C, Vega-Prieto MJ, Diez-Fuentes ML, Luis Lima S, Salido E, Torres A. Glucose homeostasis changes and pancreatic beta-cell proliferation after switching to cyclosporin in tacrolimus-induced diabetes mellitus. Nefrologia. 2015;35(3):264-72. doi: 10.1016/j.nefro.2015.05.007. Epub 2015 Jun 27. English, Spanish.
PubMed 26299169Rodriguez-Rodriguez AE, Trinanes J, Velazquez-Garcia S, Porrini E, Vega Prieto MJ, Diez Fuentes ML, Arevalo M, Salido Ruiz E, Torres A. The higher diabetogenic risk of tacrolimus depends on pre-existing insulin resistance. A study in obese and lean Zucker rats. Am J Transplant. 2013 Jul;13(7):1665-75. doi: 10.1111/ajt.12236. Epub 2013 May 7.
PubMed 23651473Delgado P, Diaz JM, Silva I, Osorio JM, Osuna A, Bayes B, Lauzurica R, Arellano E, Campistol JM, Dominguez R, Gomez-Alamillo C, Ibernon M, Moreso F, Benitez R, Lampreave I, Porrini E, Torres A. Unmasking glucose metabolism alterations in stable renal transplant recipients: a multicenter study. Clin J Am Soc Nephrol. 2008 May;3(3):808-13. doi: 10.2215/CJN.04921107. Epub 2008 Mar 5.
PubMed 18322043
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimum Immunosuppression in Renal Transplant Recipients at High Risk of Developing New Onset Diabetes After Transplantation: A Multicenter, Prospective, Controlled and Randomized Trial.
- ClinicalTrials.gov ID
- NCT01002339
- Acronym / sponsor ID
- 01-DMPT / FundacionRC
- Conditions
- Diabetes Mellitus, Adult-Onset
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated: higher rate of acute rejection in the Cyclosporin A group
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Armando Torres RamírezUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Posted 3 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. Cyclosporine (CsA) and Tacrolimus are the basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection and graft function. However, Tacrolimus increases 2 times the risk of NODAT as compared to CsA.
Detailed description
New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. CsA and Tacrolimus are the basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection and graft function. However, increases 2 times the risk of NODAT as compared to CsA. Objectives: a) To compare the incidence of NODAT and glucose intolerance with 3 different regimes: Tacrolimus with rapid steroid withdrawal; Tacrolimus with steroids minimization; and CsA with steroid minimization; b) To compare acute rejection rate, renal function and graft and patient survival between different regimes; and c) to investigate the influence of different regimes on subclinical atheromatosis. A total of 210 patients will be randomized. The primary efficacy variable will be NODAT or glucose intolerance at 1 year; secondary efficacy variables will be acute rejection, renal function, and changes of carotid intima-media thickness over time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus with rapid steroid withdrawal | Experimental | Drug: Tacrolimus with rapid steroid withdrawalBasiliximab induction. Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week. |
| Tacrolimus with steroids minimization | Active comparator | Drug: Tacrolimus with steroids minimizationBasiliximab induction.Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal |
| CsA with steroid minimization | Experimental | Drug: CsA with steroid minimizationBasiliximab induction. Ciclosporin A (CsA) plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary renal transplant recipients with end stage renal disease
- No prior history of diabetes mellitus before transplant
- Absence of Immunologic risk defined by the investigator criterion and Panel Reactive Antibody (PRA) < 50%
- Absence of severe infection and hepatitis C or B infection
- Efficient contraception in women during the study
Key exclusion criteria (6 listed)
- Patients with type I or II diabetes prior to transplantation defined by the American Diabetes Association (ADA) criteria
- Recipient age under 45
- Patients receiving a second renal transplant
- Patients with high immunological risk or PRA (panel reactive antibody level) >or =50%
- Severe infection or hepatitis C or B infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tacrolimus with rapid steroid withdrawalAlso: Simulect; Dacortin; Prograf/Advagraf; Cellcept/Myfortic.* Basiliximab induction (4 mg i.v., days 0 and 4). * Corticosteroids: 0.5 gr of i.v. Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. * Tacrolimus: 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month and then 5-8 ng/ml. * Mycophenolate mofetil 1 gr b.i.d. for the first month and then 500 mg b.i.d. | Drug | Tacrolimus with rapid steroid withdrawal |
| Tacrolimus with steroids minimizationAlso: Simulect; Dacortin; Prograf/Advagraf; Cellcept/Myfortic.* Basiliximab induction (4 mg i.v., days 0 an 4) * Corticosteroids: 0.5 gr of i.v. MP intraoperatively and 60 mg on the first day, followed by oral doses of prednisone starting with 0.3 mg/Kg/day, and gradual weekly tapering to complete discontinuation over 6 months. * Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month and then 5-8 ng/ml. * Mycophenolate mofetil 1 gr b.i.d. for the first month and then 500 mg b.i.d. | Drug | Tacrolimus with steroids minimization |
| CsA with steroid minimizationAlso: Simulect; Dacortin; Sandimmun Neoral; Cellcept/Myfortic.* Basiliximab induction (4 mg i.v., days 0 an 4) * Corticosteroids: 0.5 gr of i.v. MP intraoperatively and 60 mg on the first day, followed by oral doses of prednisone starting with 0.3 mg/Kg/day, and gradual weekly tapering to complete discontinuation over 6 months. * CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month and then 100-150 ng/ml. * Mycophenolate mofetil 1 gr b.i.d | Drug | CsA with steroid minimization |
Primary outcome
Primary Outcome Measure "New Onset Diabetes After Renal Transplantation" (NODAT)
Time frame: 1 year
American Diabetes Association criteria (ADA) including an oral glucose tolerance test.
Patients Treated With Insulin or Oral Antidiabetic Drugs
Time frame: 1 year
Primary Outcome Measure (Glucose Intolerance)
Time frame: 1 year
Glycemia >=140 and <200 mg/dl, 2 hours after a standard oral glucose tolerance test. Measured values: glucose intolerance at 1 year defined by ADA criteria.
13 secondary outcomes
Rejection
Time frame: 1 year
Renal Function
Time frame: 1 year
Proteinuria
Time frame: 1 year
Blood Pressure
Time frame: 1 year
Blood Pressure
Time frame: 1 year
Number of Antihypertensive Drugs Patients Reported Taking.
Time frame: 1 year
Lipidic Profile (Triglycerides)
Time frame: 1 year
Lipidic Profile (Cholesterol)
Time frame: 1 year
Lipidic Profile (HDL-c)
Time frame: 1 year
Lipidic Profile (LDL-c)
Time frame: 1 year
Percentage of Patients Using Statins
Time frame: 1 year
Changes of Carotid Intima-media Thickness Over Time
Time frame: 1 year
Percentage of Patients Using Acetylsalicylic Acid (ASA)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17395658Porrini E, Gomez MD, Alvarez A, Cobo M, Gonzalez-Posada JM, Perez L, Hortal L, Garcia JJ, Dolores Checa M, Morales A, Hernandez D, Torres A. Glycated haemoglobin levels are related to chronic subclinical inflammation in renal transplant recipients without pre-existing or new onset diabetes. Nephrol Dial Transplant. 2007 Jul;22(7):1994-9. doi: 10.1093/ndt/gfm067. Epub 2007 Mar 29.
- Background: PubMed 17984840Alvarez A, Fernandez J, Porrini E, Delgado P, Pitti S, Vega MJ, Gonzalez-Posada JM, Rodriguez A, Perez L, Marrero D, Luis D, Velazquez S, Hernandez D, Salido E, Torres A. Carotid atheromatosis in nondiabetic renal transplant recipients: the role of prediabetic glucose homeostasis alterations. Transplantation. 2007 Oct 15;84(7):870-5. doi: 10.1097/01.tp.0000284462.70064.ae.
- Background: PubMed 17893603Hernandez D, Miquel R, Porrini E, Fernandez A, Gonzalez-Posada JM, Hortal L, Checa MD, Rodriguez A, Garcia JJ, Rufino M, Torres A. Randomized controlled study comparing reduced calcineurin inhibitors exposure versus standard cyclosporine-based immunosuppression. Transplantation. 2007 Sep 27;84(6):706-14. doi: 10.1097/01.tp.0000282872.17024.b7.
- Background: PubMed 18029372Porrini E, Delgado P, Alvarez A, Cobo M, Perez L, Gonzalez-Posada JM, Hortal L, Gallego R, Garcia JJ, Checa M, Morales A, Salido E, Hernandez D, Torres A. The combined effect of pre-transplant triglyceride levels and the type of calcineurin inhibitor in predicting the risk of new onset diabetes after renal transplantation. Nephrol Dial Transplant. 2008 Apr;23(4):1436-41. doi: 10.1093/ndt/gfm762. Epub 2007 Nov 19.
- Background: PubMed 18431233Porrini E, Moreno JM, Osuna A, Benitez R, Lampreabe I, Diaz JM, Silva I, Dominguez R, Gonzalez-Cotorruelo J, Bayes B, Lauzurica R, Ibernon M, Moreso F, Delgado P, Torres A. Prediabetes in patients receiving tacrolimus in the first year after kidney transplantation: a prospective and multicenter study. Transplantation. 2008 Apr 27;85(8):1133-8. doi: 10.1097/TP.0b013e31816b16bd.
- Background: PubMed 18957019Bayes B, Moreso F, Benitez R, Torres A, Diaz JM, Granada ML, Lauzurica R, Pastor MC, Teixido J. [Post-transplant diabetes mellitus depending on the pre-transplant dialysis technique]. Nefrologia. 2008;28 Suppl 6:97-102. Spanish.
- Background: PubMed 19155984Porrini E, Bayes B, Diaz JM, Ibernon M, Benitez R, Dominguez R, Moreno JM, Delgado P, Lauzurica R, Silva I, Moreso F, Lampreabe I, Arias M, Osuna A, Torres A. Hyperinsulinemia and hyperfiltration in renal transplantation. Transplantation. 2009 Jan 27;87(2):274-9. doi: 10.1097/TP.0b013e318191a7d5.
- Background: PubMed 26538615Porrini EL, Diaz JM, Moreso F, Delgado Mallen PI, Silva Torres I, Ibernon M, Bayes-Genis B, Benitez-Ruiz R, Lampreabe I, Lauzurrica R, Osorio JM, Osuna A, Dominguez-Rollan R, Ruiz JC, Jimenez-Sosa A, Gonzalez-Rinne A, Marrero-Miranda D, Macia M, Garcia J, Torres A. Clinical evolution of post-transplant diabetes mellitus. Nephrol Dial Transplant. 2016 Mar;31(3):495-505. doi: 10.1093/ndt/gfv368. Epub 2015 Nov 3.
- Background: PubMed 26299169Rodriguez-Rodriguez AE, Trinanes J, Porrini E, Velazquez-Garcia S, Fumero C, Vega-Prieto MJ, Diez-Fuentes ML, Luis Lima S, Salido E, Torres A. Glucose homeostasis changes and pancreatic beta-cell proliferation after switching to cyclosporin in tacrolimus-induced diabetes mellitus. Nefrologia. 2015;35(3):264-72. doi: 10.1016/j.nefro.2015.05.007. Epub 2015 Jun 27. English, Spanish.
- Background: PubMed 23651473Rodriguez-Rodriguez AE, Trinanes J, Velazquez-Garcia S, Porrini E, Vega Prieto MJ, Diez Fuentes ML, Arevalo M, Salido Ruiz E, Torres A. The higher diabetogenic risk of tacrolimus depends on pre-existing insulin resistance. A study in obese and lean Zucker rats. Am J Transplant. 2013 Jul;13(7):1665-75. doi: 10.1111/ajt.12236. Epub 2013 May 7.
- Results publication: PubMed 18322043Delgado P, Diaz JM, Silva I, Osorio JM, Osuna A, Bayes B, Lauzurica R, Arellano E, Campistol JM, Dominguez R, Gomez-Alamillo C, Ibernon M, Moreso F, Benitez R, Lampreave I, Porrini E, Torres A. Unmasking glucose metabolism alterations in stable renal transplant recipients: a multicenter study. Clin J Am Soc Nephrol. 2008 May;3(3):808-13. doi: 10.2215/CJN.04921107. Epub 2008 Mar 5.
- Individual participant dataSharing planned: Undecided
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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Armando Torres, PhD study director
Fundación Canaria para la Investigación Biomédica Rafael Clavijo
10 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 Tacrolimus with rapid steroid withdrawal, Tacrolimus with steroids minimization and CsA with steroid minimization in people with Diabetes Mellitus, Adult-Onset, run by Armando Torres Ramírez at 10 sites in Spain.
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 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. 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 3 Aug 2016). 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?
Primary Outcome Measure "New Onset Diabetes After Renal Transplantation" (NODAT) (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT01002339, which also lists 11 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 22 Oct 2024.