Disorder Related to Renal TransplantationNCT02540395
Prospective Donor Specific T Response Measurment for IS Minimization in de Novo Renal Transplantation
A study testing Tacrolimus (for Group B), MMF (mycophenolate mofetil) (for Group B) and 6-methyl prednisolone (Steroids) (for Group B) in people with Disorder Related to Renal Transplantation and Effects of Immunosuppressant Therapy, run by Prof. Dr. Petra Reinke at 8 sites in 6 countries.
Trial summary
The main objective of the study is to demonstrate the utility and safety of the IFN-γ (Interferon Gamma) ELISPOT (Enzyme-linked immunosorbent spot) marker for the stratification of kidney transplant recipients into low and high IS (Immunosuppression) regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder Related to Renal Transplantation, Effects of Immunosuppressant Therapy
- What is being tested?
- Tacrolimus (for Group B), MMF (mycophenolate mofetil) (for Group B) and 6-methyl prednisolone (Steroids) (for Group B)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 8 sitesin 6 countries
- Study dates
- Mar 2015to 31 Oct 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, age ≥18 years.
- Subject must be a recipient of a first renal transplant from a deceased or living donor.
- Subject must have a current documented PRA (Panel of reactive antibodies) <20% and no detectable anti-class I and II HLA (human leukocyte Antigens) antibodies by solid phase assay (Luminex®).
- Subject is willing to provide signed written informed consent.
- Women of Childbearing Potential (WOCBP) must be using a highly effective method of contraception (Pearl-Index < 1) to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL]. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG (Human chorionic gonadotropin)) within 72 hours prior to the start of clinical trial.
Who cannot join
- Subjects undergoing renal transplant with a current documented PRA >20% and/or detectable anti-class I and II HLA antibodies by solid phase assay (Luminex®).
- CDC (complement dependent cytotoxicity) positive cross match.
- Subjects receiving an allograft from a donor older than 65 years with elevated creatinine levels and/or treated diabetes.
- Cold ischemia time (CIT) higher than 24h.
- Subjects with a prior solid organ transplant (SOT), including renal re-transplantation, or receiving a concurrent SOT.
- Patients previously treated with daclizumab or basiliximab.
Show all 21Show fewer
- Subjects with underlying renal disease of:
- Primary focal segmental glomerulosclerosis.
- Type I or II membranoproliferative glomerulonephritis
- Atypical Haemolytic uremic syndrome (HUS) / thrombotic thrombocytopenic purpura syndrome.
- Subject with Hepatitis B chronic infection and/or active infection by Hepatitis C virus (positive PCR (polymerase chain reaction result) at the moment of transplant.
- Subjects with known human immunodeficiency virus (HIV) infection.
- Patients with active systemic infection that requires the continued use of antibiotics.
- Patients with neoplasia except localized skin cancer receiving appropriate treatment.
- Patients with severe anemia (hemoglobin < 6g/dl), leucopenia (WBC (White blood cells) <2500/mm3), thrombocytopenia (platelets <80.000/mm3).
- Hemodynamically instable patients even if their hemoglobin level counts > 6 g/dl.
- Patients with intestinal pathology or severe diarrhoea that can hinder absorption according to medical criteria.
- Subjects with a known hypersensibility to any of the drugs used in this protocol.
- Subjects who have used any investigational drug within 30 days prior to enrolment in this clinical trial.
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period, women who are pregnant or breastfeeding or women with a positive pregnancy test on enrolment.
- Subjects who are legally detained in an official institution
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Germany3 sites
Department Nephrology and BCRT, Charité Universitätsmedizin Berlin
Berlin, 13353
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Universitätsklinikum Regensburg
Regensburg
Czechia1 site
Institut klinické a experimentální mediciny
Prague, Prague 4, 14021
Netherlands1 site
Academisch Medisch Centrum bij de Universiteit van Amsterdam
Amsterdam
Spain1 site
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Prospective Donor-specific Cellular Alloresponse Assessment for Immunosuppression Minimization in de Novo Renal Transplantation
The main objective of the study is to demonstrate the utility and safety of the IFN-γ (Interferon Gamma) ELISPOT (Enzyme-linked immunosorbent spot) marker for the stratification of kidney transplant recipients into low and high IS (Immunosuppression) regimens. The enrichment study will test non-inferiority of low IS regimen compared to high IS regimen, assuming 10% of BPAR at 6-months in the control group, and allowing a non-inferiority limit of maximum 10%.
- Being tested
- Tacrolimus (for Group B), MMF (mycophenolate mofetil) (for Group B), 6-methyl prednisolone (Steroids) (for Group B), Tacrolimus (for Group A), Mycofenolate mofetil (MMF) (for Group A)
- Keywords
- Kidney transplantation, Immunosuppression, IFN-γ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus (for Group B)Drug
Also called Prograf
Tacrolimus (for Group B) will be administered orally twice a day (bid). Tacrolimus (for Group B) will be initially given at the 0,1mg/kg bid to achieve a stable 12-hour trough level of 8-10 ng/mL during the first month after transplantation to progressively tapper to 6-8ng/ml thereafter.
MMF (mycophenolate mofetil) (for Group B)Drug
Also called Cellcept, Myfortic, Myfenax
MMF (mycophenolate mofetil) will be administered orally to patients in group B at conventional doses (1gr/12h) before transplant procedure and during the first 7 days after transplant. For subjects who develop nausea, diarrhea, or other MMF(mycophenolate mofetil) -related gastrointestinal adverse effects (eg, symptoms fully assessed and deemed not to have an etiology other than intolerability to MMF), the MMF(mycophenolate mofetil) dose may be decreased to the maximally tolerated dose.
Subjects unable to tolerate the reduced dose may be converted to mycophenolate sodium (Myfortic™) or to Myfenax.
From day 8 on, patients will not receive MMF.
6-methyl prednisolone (Steroids) (for Group B)Drug
Also called Urbason, Methypred
At the time of surgery, all patients will receive 500mg of 6-methyl prednisolone (Steroids, Urbason, Methypred).
Patients in group B will receive 250mg of 6-methyl prednisolone (or equivalent) on day 2, 125 mg on day 3, 60 mg on day 4 and 30 mg on day 5. From day 6 on, patients will receive 0.25 mg/kg/d of 6-methyl-prednisolone (Steroids, Urbason, Methypred) until month 1, then tapering until discontinuation on month 2 will be performed.
Tacrolimus (for Group A)Drug
Also called Prograf
The study group A will receive Tacrolimus (for Group A) (Prograf) to achieve 4-8 ng/ml trough levels during all the duration of the study.
Tacrolimus (for Group A) (Tacrolimus) capsules should generally be administered on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal, to achieve maximal absorption.
Mycofenolate mofetil (MMF) (for Group A)Drug
Also called Cellcept, Myfortic, Myfenax
Mycophenolate mofetil (MMF) (Cellcept, Myfortic, Myfenax) (for Group A) will be administered orally to patients in group A at conventional doses (1gr/12h). For subjects who develop nausea, diarrhea, or other Mycophenolate mofetil (MMF) (for Group A) -related gastrointestinal adverse effects (eg, symptoms fully assessed and deemed not to have an etiology other than intolerability to Mycophenolate mofetil (MMF) (for Group A), the Mycophenolate mofetil (MMF) (for Group A) dose may be decreased to the maximally tolerated dose.
Subjects unable to tolerate the reduced dose may be converted to mycophenolate sodium (Myfortic™).
The first dose of Mycophenolate mofetil (MMF) (for Group A) should be administered before transplantation.
6-methyl prednisolone (Steroids) (for Group A)Drug
Also called Urbason, Methypred
At the time of surgery, all patients will receive 500 mg of 6-methyl prednisolone (steroids for Group A).
Patients in arm A will receive 20 mg/day of 6-methyl prednisolone (steroids for Group A) (or the equivalent) during the first 2 weeks after transplantation, then tapering to 15 mg from week 3 to week 4 to finally be maintained at 5mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Standard of care | Active comparator | Standard of care immunosuppressive regimen based on TAC (Prograf) (achieving 4-8ng/ml trough levels), MMF (Cellcept, Myfortic, Myfenax)(1gr bid) and steroids (6-methyl prednisolone, Urbason, Methypred) (according to KDIGO guidelines).
All patients in group A recieve the tripple-drug IS as suggested by guidelines. In case of rejection the patients are treated with high dosage of Methypred and/or Thymoglobuline Receives: Drug: Tacrolimus (for Group A); Drug: Mycofenolate mofetil (MMF) (for Group A); Drug: 6-methyl prednisolone (Steroids) (for Group A) |
| Group B: "Low" Immunosuppression regimen | Experimental | (based on TAC monotherapy (Prograf) to achieve 8-10 ng/ml trough levels during the first 4 weeks after transplantation and 6-8 ng/ml thereafter, MMF (Cellcept, Myfortic, Myfenax) (1g bid) during the first 7 days post-transplant and stopped thereafter) and steroids (6-methyl prednisolone; Urbason, Methypred) (tapering until discontinuation on month 2 post-transplant).
In contrast to Group A the patients are treated with a two drug IS combination consisting of Prograf and Methypred. In case of rejection the patients are treated with hifg dosage of Methypred and/or Thymoglobuline. Receives: Drug: Tacrolimus (for Group B); Drug: MMF (mycophenolate mofetil) (for Group B); Drug: 6-methyl prednisolone (Steroids) (for Group B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of anti-donor T-cell alloresponses using the IFN-γ ELISPOT test
Patients with a positive anti-donor IFN-γ ELISPOT assay result (>25 spots/300.000 PBMC (peripheral blood mononuclear cells )) will be ruled out of the study and patients with negative anti-donor IFN-γ ELISPOT test (<25 spots/300.000 PBMC) will be randomized in 2 different groups (1:1).
The main objective of the study is to demonstrate the utility and safety of the IFN-γ ELISPOT marker for the stratification of kidney transplant recipients into low and high IS regimens.
Measured: 6 months
Secondary outcomes (20)
Differences across Treatment arms in eGFR (estimated glomerular Filtration rate) (ml/min)
Measured: after 3, 6 and 12 months
Differences across Treatment arms in Biopsy proven acute rejection rate (BPAR rate)
Measured: after 6 and 12 months
Differences across Treatment arms in subclinical rejection rate using renal allograft biopsy
Measured: after 3 and 12 months
Differences across Treatment arms in Prevalence of death, and graft loss
Measured: after 6 and 12 months
Differences across Treatment arms in Prevalence of metabolic and cardiovascular co-morbidity (new onset diabetes mellitus (NODAT, dyslipidaemias, hypertension)
Measured: 12 months
Differences across Treatment arms in Prevalence of subjects that remain MMF and steroid-free
Measured: after 6 and 12 months
Differences across Treatment arms in Prevalence of Acute and chronic histologic lesions assessed by the Bannf'11 score in protocol biopsies
Measured: after 3 and 12 months
Differences across Treatment arms in Prevalence of patients that remain on Therapy
Measured: after 12 months
Differences across Treatment arms in Distribution of patients in distinct chronic kidney diseases (CKD) stages
Measured: after 12 months
Differences across Treatment arms in treatment cost (cost/benefit)
Measured: after 1,3,6,12 and 24 months
Differences across Treatment arms in development of a Panel reactive T (PRT)-cell response platform to evaluate general anti-HLA T-cell Responses using ELISPOT
Measured: at pre-transplantation, 3, 6 and 12 months after transplantation as well as at time of BPAR
Differences across Treatment arms in assessment of anti-donor and anti-HLA antibodies by Solid phase assays (Luminex®) and B-cell ELISPOT
Measured: at pre-transplantation, 3, 6 and 12 months after transplantation as well as at time of BPAR
Differences across Treatment arms in different viral load (CMV, EBV, BKV)
Measured: at months 1, 2, 3, 6 and 12 after transplantation
Differences across Treatment arms in study of virus-specific T-cell responses (ELISPOT)
Measured: at at pre-transplantation, 3, 6 and 12 after transplantation
Differences across Treatment arms in prevalence of transcriptional genes by RT-PCR in PBMC (peripheral blood mononuclear cells )
Measured: at pre-transplantation and months 1, 3, 6 and 12 after transplantation as well as at time of BPAR
Differences across Treatment arms in flow cytometry assessment of peripheral blood mononuclear cells (PBMC)
Measured: at pre-transplantation and months 1, 3, 6 and 12 after transplantation as well as at time of BPAR
Differences across Treatment arms in Quantitative analyses of urinary IP-10 (Interferon Gamma induced Protein)
Measured: at 4 weeks and at 3, 6 and 12 month after transplantation as well as at time of BPAR
Differences across Treatment arms in Assessment of protocol biopsies
Measured: at month 3 and 12 after transplantation
Differences across Treatment arms in MicroRNA assessment in sera and urine
Measured: at pre-transplantation and months 1, 3, 6 and 12 after transplantation
Differences across Treatment arms in evaluation of FOXP3 (Forkhead box P3) methylation degree at the TSDR (Treg-specific demethylated Region)
Measured: at pre-transplantation and months 1, 3, 6 and 12 after transplantation as well as at time of rejection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder Related to Renal 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Petra Reinke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Petra Reinke, Charite University, Berlin, Germany
- Investigators
- Josep M. Grinyó, Prof. Dr., Principal investigator, Renal Transplant Unit, Department Nephrology Bellvitge Universitari Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540395
- Sponsor's protocol ID
- CELLIMIN
- Other IDs
- 2014-001325-33, 2014
- Status last verified
- Jan 2021
- First submitted
- 19 Aug 2015
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Donor-specific Cellular Alloresponse Assessment for Immunosuppression Minimization in de Novo Renal Transplantation
- ClinicalTrials.gov ID
- NCT02540395
- Acronym / sponsor ID
- CELLIMIN
- Keywords
- Kidney transplantation, Immunosuppression, IFN-γ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Prof. Dr. Petra ReinkeUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 4 Sep 2015 (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 main objective of the study is to demonstrate the utility and safety of the IFN-γ (Interferon Gamma) ELISPOT (Enzyme-linked immunosorbent spot) marker for the stratification of kidney transplant recipients into low and high IS (Immunosuppression) regimens. The enrichment study will test non-inferiority of low IS regimen compared to high IS regimen, assuming 10% of BPAR at 6-months in the control group, and allowing a non-inferiority limit of maximum 10%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Standard of care | Active comparator | Drug: Tacrolimus (for Group A), Drug: Mycofenolate mofetil (MMF) (for Group A), Drug: 6-methyl prednisolone (Steroids) (for Group A)Standard of care immunosuppressive regimen based on TAC (Prograf) (achieving 4-8ng/ml trough levels), MMF (Cellcept, Myfortic, Myfenax)(1gr bid) and steroids (6-methyl prednisolone, Urbason, Methypred) (according to KDIGO guidelines). All patients in group A recieve the tripple-drug IS as suggested by guidelines. In case of rejection the patients are treated with high dosage of Methypred and/or Thymoglobuline |
| Group B: "Low" Immunosuppression regimen | Experimental | Drug: Tacrolimus (for Group B), Drug: MMF (mycophenolate mofetil) (for Group B), Drug: 6-methyl prednisolone (Steroids) (for Group B)(based on TAC monotherapy (Prograf) to achieve 8-10 ng/ml trough levels during the first 4 weeks after transplantation and 6-8 ng/ml thereafter, MMF (Cellcept, Myfortic, Myfenax) (1g bid) during the first 7 days post-transplant and stopped thereafter) and steroids (6-methyl prednisolone; Urbason, Methypred) (tapering until discontinuation on month 2 post-transplant). In contrast to Group A the patients are treated with a two drug IS combination consisting of Prograf and Methypred. In case of rejection the patients are treated with hifg dosage of Methypred and/or Thymoglobuline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women, age ≥18 years.
- Subject must be a recipient of a first renal transplant from a deceased or living donor.
- Subject must have a current documented PRA (Panel of reactive antibodies) <20% and no detectable anti-class I and II HLA (human leukocyte Antigens) antibodies by solid phase assay (Luminex®).
- Subject is willing to provide signed written informed consent.
- Women of Childbearing Potential (WOCBP) must be using a highly effective method of contraception (Pearl-Index < 1) to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL]. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG (Human chorionic gonadotropin)) within 72 hours prior to the start of clinical trial.
Key exclusion criteria (21 listed)
- Subjects undergoing renal transplant with a current documented PRA >20% and/or detectable anti-class I and II HLA antibodies by solid phase assay (Luminex®).
- CDC (complement dependent cytotoxicity) positive cross match.
- Subjects receiving an allograft from a donor older than 65 years with elevated creatinine levels and/or treated diabetes.
- Cold ischemia time (CIT) higher than 24h.
- Subjects with a prior solid organ transplant (SOT), including renal re-transplantation, or receiving a concurrent SOT.
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 (for Group B)Also: PrografTacrolimus (for Group B) will be administered orally twice a day (bid). Tacrolimus (for Group B) will be initially given at the 0,1mg/kg bid to achieve a stable 12-hour trough level of 8-10 ng/mL during the first month after transplantation to progressively tapper to 6-8ng/ml thereafter. | Drug | Group B: "Low" Immunosuppression regimen |
| MMF (mycophenolate mofetil) (for Group B)Also: Cellcept, Myfortic, MyfenaxMMF (mycophenolate mofetil) will be administered orally to patients in group B at conventional doses (1gr/12h) before transplant procedure and during the first 7 days after transplant. For subjects who develop nausea, diarrhea, or other MMF(mycophenolate mofetil) -related gastrointestinal adverse effects (eg, symptoms fully assessed and deemed not to have an etiology other than intolerability to MMF), the MMF(mycophenolate mofetil) dose may be decreased to the maximally tolerated dose. Subjects unable to tolerate the reduced dose may be converted to mycophenolate sodium (Myfortic™) or to Myfenax. From day 8 on, patients will not receive MMF. | Drug | Group B: "Low" Immunosuppression regimen |
| 6-methyl prednisolone (Steroids) (for Group B)Also: Urbason, MethypredAt the time of surgery, all patients will receive 500mg of 6-methyl prednisolone (Steroids, Urbason, Methypred). Patients in group B will receive 250mg of 6-methyl prednisolone (or equivalent) on day 2, 125 mg on day 3, 60 mg on day 4 and 30 mg on day 5. From day 6 on, patients will receive 0.25 mg/kg/d of 6-methyl-prednisolone (Steroids, Urbason, Methypred) until month 1, then tapering until discontinuation on month 2 will be performed. | Drug | Group B: "Low" Immunosuppression regimen |
| Tacrolimus (for Group A)Also: PrografThe study group A will receive Tacrolimus (for Group A) (Prograf) to achieve 4-8 ng/ml trough levels during all the duration of the study. Tacrolimus (for Group A) (Tacrolimus) capsules should generally be administered on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal, to achieve maximal absorption. | Drug | Group A: Standard of care |
| Mycofenolate mofetil (MMF) (for Group A)Also: Cellcept, Myfortic, MyfenaxMycophenolate mofetil (MMF) (Cellcept, Myfortic, Myfenax) (for Group A) will be administered orally to patients in group A at conventional doses (1gr/12h). For subjects who develop nausea, diarrhea, or other Mycophenolate mofetil (MMF) (for Group A) -related gastrointestinal adverse effects (eg, symptoms fully assessed and deemed not to have an etiology other than intolerability to Mycophenolate mofetil (MMF) (for Group A), the Mycophenolate mofetil (MMF) (for Group A) dose may be decreased to the maximally tolerated dose. Subjects unable to tolerate the reduced dose may be converted to mycophenolate sodium (Myfortic™). The first dose of Mycophenolate mofetil (MMF) (for Group A) should be administered before transplantation. | Drug | Group A: Standard of care |
| 6-methyl prednisolone (Steroids) (for Group A)Also: Urbason, MethypredAt the time of surgery, all patients will receive 500 mg of 6-methyl prednisolone (steroids for Group A). Patients in arm A will receive 20 mg/day of 6-methyl prednisolone (steroids for Group A) (or the equivalent) during the first 2 weeks after transplantation, then tapering to 15 mg from week 3 to week 4 to finally be maintained at 5mg/day. | Drug | Group A: Standard of care |
Primary outcome
assessment of anti-donor T-cell alloresponses using the IFN-γ ELISPOT test
Time frame: 6 months
Patients with a positive anti-donor IFN-γ ELISPOT assay result (>25 spots/300.000 PBMC (peripheral blood mononuclear cells )) will be ruled out of the study and patients with negative anti-donor IFN-γ ELISPOT test (<25 spots/300.000 PBMC) will be randomized in 2 different groups (1:1). The main objective of the study is to demonstrate the utility and safety of the IFN-γ ELISPOT marker for the stratification of kidney transplant recipients into low and high IS regimens.
20 secondary outcomes
Differences across Treatment arms in eGFR (estimated glomerular Filtration rate) (ml/min)
Time frame: after 3, 6 and 12 months
Differences across Treatment arms in Biopsy proven acute rejection rate (BPAR rate)
Time frame: after 6 and 12 months
Differences across Treatment arms in subclinical rejection rate using renal allograft biopsy
Time frame: after 3 and 12 months
Differences across Treatment arms in Prevalence of death, and graft loss
Time frame: after 6 and 12 months
Differences across Treatment arms in Prevalence of metabolic and cardiovascular co-morbidity (new onset diabetes mellitus (NODAT, dyslipidaemias, hypertension)
Time frame: 12 months
Differences across Treatment arms in Prevalence of subjects that remain MMF and steroid-free
Time frame: after 6 and 12 months
Differences across Treatment arms in Prevalence of Acute and chronic histologic lesions assessed by the Bannf'11 score in protocol biopsies
Time frame: after 3 and 12 months
Differences across Treatment arms in Prevalence of patients that remain on Therapy
Time frame: after 12 months
Differences across Treatment arms in Distribution of patients in distinct chronic kidney diseases (CKD) stages
Time frame: after 12 months
Differences across Treatment arms in treatment cost (cost/benefit)
Time frame: after 1,3,6,12 and 24 months
Differences across Treatment arms in development of a Panel reactive T (PRT)-cell response platform to evaluate general anti-HLA T-cell Responses using ELISPOT
Time frame: at pre-transplantation, 3, 6 and 12 months after transplantation as well as at time of BPAR
Differences across Treatment arms in assessment of anti-donor and anti-HLA antibodies by Solid phase assays (Luminex®) and B-cell ELISPOT
Time frame: at pre-transplantation, 3, 6 and 12 months after transplantation as well as at time of BPAR
Differences across Treatment arms in different viral load (CMV, EBV, BKV)
Time frame: at months 1, 2, 3, 6 and 12 after transplantation
Differences across Treatment arms in study of virus-specific T-cell responses (ELISPOT)
Time frame: at at pre-transplantation, 3, 6 and 12 after transplantation
Differences across Treatment arms in prevalence of transcriptional genes by RT-PCR in PBMC (peripheral blood mononuclear cells )
Time frame: at pre-transplantation and months 1, 3, 6 and 12 after transplantation as well as at time of BPAR
Differences across Treatment arms in flow cytometry assessment of peripheral blood mononuclear cells (PBMC)
Time frame: at pre-transplantation and months 1, 3, 6 and 12 after transplantation as well as at time of BPAR
Differences across Treatment arms in Quantitative analyses of urinary IP-10 (Interferon Gamma induced Protein)
Time frame: at 4 weeks and at 3, 6 and 12 month after transplantation as well as at time of BPAR
Differences across Treatment arms in Assessment of protocol biopsies
Time frame: at month 3 and 12 after transplantation
Differences across Treatment arms in MicroRNA assessment in sera and urine
Time frame: at pre-transplantation and months 1, 3, 6 and 12 after transplantation
Differences across Treatment arms in evaluation of FOXP3 (Forkhead box P3) methylation degree at the TSDR (Treg-specific demethylated Region)
Time frame: at pre-transplantation and months 1, 3, 6 and 12 after transplantation as well as at time of rejection
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 1 Feb 2021.
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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.
Josep M. Grinyó, Prof. Dr. principal investigator
Renal Transplant Unit, Department Nephrology Bellvitge Universitari Hospital
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tacrolimus (for Group B), MMF (mycophenolate mofetil) (for Group B) and 6-methyl prednisolone (Steroids) (for Group B) in people with Disorder Related to Renal Transplantation and Effects of Immunosuppressant Therapy, run by Prof. Dr. Petra Reinke at 8 sites in 6 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 5 inclusion and 21 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 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Czechia, France, Netherlands, Spain and 1 more country. 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.
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?
assessment of anti-donor T-cell alloresponses using the IFN-γ ELISPOT test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.