Renal TransplantationPhase 1ODORATNCT06744400
Optimal Dose of Anti-lymphocyte Globulin in Kidney Transplant Recipients With Low Immunological Risk
A Phase 1 study testing Grafalon® administered during 5 consecutive days at 2 mg/kg/j, Grafalon® administered during 5 consecutive days at 1 mg/kg/j and Grafalon® administered during 5 consecutive days at 0,5 mg/kg/j in people with Renal Transplantation, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
Antithymocyte globulins (ATG) are the gold standard of induction therapies and are currently used to prevent or treat acute rejection in solid organ transplantation. They induce rapid depletion of immune cells, particularly T lymphocytes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Grafalon® administered during 5 consecutive days at 2 mg/kg/j, Grafalon® administered during 5 consecutive days at 1 mg/kg/j and Grafalon® administered during 5 consecutive days at 0,5 mg/kg/j
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 15 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Females must be using highly effective contraceptive measures (see Section V-9), and have a negative pregnancy test prior to the start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening :
- Post-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.
- Women under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution.
- Women with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- Male patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 6 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing study treatment.
Show all 9Show fewer
- Patient affiliated to or beneficiary of French social security system
- Signed and dates informed consent
- Patient receiving first kidney transplantation
Who cannot join
- Current participation in a study of an investigational agent or in the period of exclusion
- Pregnant or breast-feeding subjects,
- Patient under guardianship, curatorship or under the protection of justice
- Subject not able to cooperate properly in the study judged by the investigator.
- Patients with bacterial, viral or mycotic and parasitic infections,History of opportunistic infection that required intensive care hospitalization in the two years preceding the transplant
- Patients with a high immunological risk of rejection:
Show all 18Show fewer
- African-American ethnicity
- Presence of a donor-specific antibody
- Blood group incompatibility
- Delayed onset of graft function (i.e donor after cardiac death)
- Cold ischemia time >24 hours
- Anti-HLA immunization (Flow PRA > or = 20%, presence of donor specific antibody before and/or at time of transplantation and with a positive CDC and FXM with historical and/or transplant day sera)
- Related donor with two-haplotype HLA matched kidneys
- Multi-organ transplant
- Previous transplant(s)
- History of cancer
- Thrombocytopenia < 50 000 platelets/µl
- Hypersensitivity to the active substance or to the excipients of Grafalon (monosodium phosphate dihydrate, phosphoric acid).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Antithymocyte globulins (ATG) are the gold standard of induction therapies and are currently used to prevent or treat acute rejection in solid organ transplantation. They induce rapid depletion of immune cells, particularly T lymphocytes. The time to immune reconstitution after ATG is characterized by significant intra- and inter-individual variability in reconstitution of immune cell subpopulations (T and B cells, NK cells, dendritic cells). This variability explains the prolonged T cell lymphopenia observed in some patients, which is a surrogate immune biomarker associated with an increased risk of death after 2 years of renal transplantation and more infections, cancers and atheromatous events. However, ATG also promotes an increase in the proportion of Treg cells. Although the underlying mechanisms are still debated, data from experimental animal models confirm the tolerogenic properties of ATG. ATGs are associated with improved allograft survival without rejection in patients at high immunological risk and are therefore indicated as first-line therapy in this population. In patients at low immunological risk, anti-CD25 monoclonal antibodies (anti-CD25mAb) are recommended as first-line therapy because ATGs are associated with a higher incidence of infections despite their equivalent efficacy in this population compared to anti-CD25mAb. However, neither the dosages nor the treatment duration of ATGs are clearly defined (recommended Grafalon® dosages range from 5 to 2 mg/kg/day for 5 to 21 days) and ATGs remain widely prescribed to allow early withdrawal of corticosteroids. Determination of optimal non-depleting doses of ATG could be of great interest because, in vitro, ATG is able to induce regulatory polarization of naïve T cells even at non-depleting doses. Thus, the use of such doses in patients with low immunological risk may be of interest in clinical practice with respect to anti-CD25mAb, particularly for their pro-regulatory properties and their low cost. This question must be clearly addressed in a pilot clinical study.
The purpose of this study is to find the optimal non-depleting dose (Maximum Tolerated Dose; MTD) of rabbit anti-human T-lymphocyte immunoglobulin (Grafalon®) to prevent the complications associated with prolonged CD4 T cell lymphopenia in low immunological risk renal transplant recipients. The primary outcome for the de-escalation study is the Dose Limiting Toxicity (DLT) defined by a T cell (CD3+) relative depletion above 30 % compared to baseline (Day 0) at the end of the Grafalon® induction treatment (Day 4).
Read more
The patients under study are adult receiving first kidney transplantation without a high immunological risk of rejection (african-American ethnicity, presence of a donor-specific antibody, blood group incompatibility, delayed onset of graft function (i.e donor after cardiac death), cold ischemia time >24 hours, anti-HLA immunization (Flow PRA > or = 20%, presence of donor specific antibody before and/or at time of transplantation and with a positive CDC and FXM with historical and/or transplant day sera), bacterial, viral or mycotic and parasitic infections, history of opportunistic infection that required intensive care hospitalization in the two years preceding the transplant, related donor with two-haplotype HLA matched kidneys, multi-organ transplant, history of cancer, thrombocytopenia < 50 000 platelets/µl, hypersensitivity to the active substance or to the excipients of Grafalon (monosodium phosphate dihydrate, phosphoric acid).
The inclusion period is one year. According to the active file of the center of Besançon, it is planned to include 2 patients per month. The maximum number of patients to include is 18. With a margin of error of 20%, it is possible to include all patients in 1 year. The duration of patient participation in the study is 1 year (one-year follow-up). Consequently, the duration of the study is estimated at 2 years (1 year of inclusion and 1 year of follow-up).
ODORAT is a monocenter, open-label, de-escalation phase1b controlled study. The study will be proposed to patients receiving a first kidney transplant and matching the criteria of inclusion. Recruitment will be achieved only in Besançon's transplant unit. The physician gives information on the study and collect informed consent. Then the treatment is assigned according to the dose determined by the dose de-escalation study. The first dose tested is the dose level at 2 mg/kg/day (level 3). This dose is the reference dose according to the current recommendations. The number of patients included at each dose is determined according to Bayesian optimal interval (BOIN) design.
The administration of treatment begin at time of transplantation according to recommendation.
The study will include 11 visits: D0 (baseline) to D4 (primary end point assessement), D7, D14, M1, M3, M6 and M12, to analyze pharmacokinetics of Grafalon and the immune phenotype.
- Conditions
- Renal Transplantation
- Being tested
- Grafalon® administered during 5 consecutive days at 2 mg/kg/j, Grafalon® administered during 5 consecutive days at 1 mg/kg/j, Grafalon® administered during 5 consecutive days at 0,5 mg/kg/j
- Keywords
- kidney transplant, anti-lymphocyte globulin, Grafalon, Immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grafalon® administered during 5 consecutive days at 2 mg/kg/jDrug
Also called Group 3
This de-escalation study was planned to investigate 3 doses level of Grafalon® administered during 5 consecutive days, i.e.:
Group 3 : 2 mg/kg/j, Group 2 : 1 mg/kg/j, Group 1 : 0,5 mg/kg/j.
Group 3 receives treatment in accordance with health recommendations as part of prophylactic treatment for acute rejection after allogeneic solid organ transplantation, at the minimum dose, i.e., 2 to 5 mg/kg/day for 5 to 21 days.
Grafalon® administered during 5 consecutive days at 1 mg/kg/jDrug
Also called Group 2
This de-escalation study was planned to investigate 3 doses level of Grafalon® administered during 5 consecutive days, i.e.:
Group 3 : 2 mg/kg/j, Group 2 : 1 mg/kg/j, Group 1 : 0,5 mg/kg/j.
Group 2 receive treatment at lower doses than the recommended dose for the same duration (5 days). Treatment begins on the day of transplantation immediately before the procedure at induction of sedation.
Grafalon® administered during 5 consecutive days at 0,5 mg/kg/jDrug
Also called Group 1
This de-escalation study was planned to investigate 3 doses level of Grafalon® administered during 5 consecutive days, i.e.:
Group 3 : 2 mg/kg/j, Group 2 : 1 mg/kg/j, Group 1 : 0,5 mg/kg/j.
Group 1 receive treatment at lower doses than the recommended dose for the same duration (5 days). Treatment begins on the day of transplantation immediately before the procedure at induction of sedation
| Study group | Role | What they receive |
|---|---|---|
| Group 3 : 2 mg/kg/j | Experimental | Group 3 receives treatment in accordance with health recommendations as part of prophylactic treatment for acute rejection after allogeneic solid organ transplantation, at the minimum dose, i.e., 2 to 5 mg/kg/day for 5 to 21 days. Receives: Drug: Grafalon® administered during 5 consecutive days at 2 mg/kg/j |
| Group 2 : 1 mg/kg/j | Experimental | Group 2 receive treatment at lower doses than the recommended dose for the same duration (5 days). Receives: Drug: Grafalon® administered during 5 consecutive days at 1 mg/kg/j |
| Group 1 : 0,5 mg/kg/j | Experimental | Group 1 receive treatment at lower doses than the recommended dose for the same duration (5 days). Receives: Drug: Grafalon® administered during 5 consecutive days at 0,5 mg/kg/j |
What is being measured
The primary outcome is the main question the study is designed to answer.
The optimal non-depleting dose (Maximum Tolerated Dose; MTD) of rabbit anti-human T-lymphocyte immunoglobulin (Grafalon®) to prevent the complications associated with prolonged CD4 T cell lymphopenia in low immunological risk renal transplant recipients.
The Dose Limiting Toxicity (DLT) defined by a T cell (CD3+) relative depletion above 30 % compared to baseline (Day 0) at the end of the Grafalon® induction treatment (Day 4).
Measured: From transplantation to the end of treatment at 4 days
Secondary outcomes (8)
The tolerance of Grafalon® in each dose level.
Toxicities: Incidence and grade for Adverse events (AEs), drug related AEs, drug related AE leading to dose reduction or discontinuation during treatment, Serious Adverse Events (SAE) and Suspected Unexpected Severe Adverse Reaction (SUSAR), according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
Measured: From transplantation to the end of the study at 1 year.
Clearance of Grafalon® during the treatment period and until month-3 in each dose level.
Pharmacokinetic study (clearance of Grafalon) including for each dose level the calculation of the plasmatic clearance evaluated by the air under curve of serum active Grafalon® concentration at day 0 and day 4 and the trough level of Grafalon® at each visit until month-3.
Measured: From transplantation to 3 month after first treatment.
Describe immune profile and immune restauration in each dose level.
The absolute count and proportion of different T and B cell subpopulations, Natural Killer (NK) cells, monocytes and neutrophils at each time point.
Measured: From transplantation to 1 year after.
Describe time to event clinical endpoints since transplantation at each dose level.
Time to Transplant failure defined as the time since transplantation to either graft loss or death with a functioning graft. Return to dialysis or retransplantation defined graft loss.
Overall survival defined as the time since transplantation to death. Time to kidney allograft acute rejection defined as the time since transplantation since to kidney allograft acute rejection.
Measured: From transplation to 1 year after.
The rate of patients with infection up to 1 year after transplantation in each dose level.
The infection up to 1 year after transplantation defined by :
- the onset of a severe bacterial infection: all bacterial infections leading to patient hospitalization)
- or an opportunistic infection: all types of infections that occur only in patients with an immune system deficiency and never in healthy patients (i.e. pneumocystis, tuberculosis, cryptococcosis, candidosis, Kaposi sarcoma, herpesviridae infections, B EBV lymphoma, HTLV T leukemia, toxoplasmosis, cryptococosis, polyomavirus viremia or disease…)
Measured: From transplantation to 1 year after
The number of infections by patients up to 1 year after transplantation in each dose level
The infection up to 1 year after transplantation defined by :
- the onset of a severe bacterial infection: all bacterial infections leading to patient hospitalization)
- or an opportunistic infection: all types of infections that occur only in patients with an immune system deficiency and never in healthy patients (i.e. pneumocystis, tuberculosis, cryptococcosis, candidosis, Kaposi sarcoma, herpesviridae infections, B EBV lymphoma, HTLV T leukemia, toxoplasmosis, cryptococosis, polyomavirus viremia or disease…).
Measured: From transplantation to 1 year after
The rate of patients with an atherosclerotic event up to 1 year after transplantation in each dose level
The atherosclerotic event up to 1 year after transplantation defined by major adverse cardiovascular events defined by coronary artery disease, cerebrovascular disease, peripheral arterial disease of the lower limbs, aortic pathology.
Measured: From transplantation to year after
Renal function at 1 year post transplant in each dose level
Renal function at 1 year post transplant evaluated by estimated glomerular filtration rate (eGFR) calculated by the creatinine clearance according to the formula CKD-EPI.
Measured: From transplantation to 1 year after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start15 Jan 2025 (estimated)
- Primary completion20 Jan 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The number of patients included at each dose is determined according to Bayesian optimal interval (BOIN) design.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744400
- Sponsor's protocol ID
- 2024/874
- Acronym
- ODORAT
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Dose of Anti-lymphocyte Globulin in Kidney Transplant Recipients With Low Immunological Risk
- ClinicalTrials.gov ID
- NCT06744400
- Acronym / sponsor ID
- ODORAT / 2024/874
- Conditions
- Renal Transplantation
- Keywords
- kidney transplant, anti-lymphocyte globulin, Grafalon, Immunosuppression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 20 Dec 2024 (actual)
- 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.
Antithymocyte globulins (ATG) are the gold standard of induction therapies and are currently used to prevent or treat acute rejection in solid organ transplantation. They induce rapid depletion of immune cells, particularly T lymphocytes. The time to immune reconstitution after ATG is characterized by significant intra- and inter-individual variability in reconstitution of immune cell subpopulations (T and B cells, NK cells, dendritic cells). This variability explains the prolonged T cell lymphopenia observed in some patients, which is a surrogate immune biomarker associated with an increased risk of death after 2 years of renal transplantation and more infections, cancers and atheromatous events. However, ATG also promotes an increase in the proportion of Treg cells. Although the underlying mechanisms are still debated, data from experimental animal models confirm the tolerogenic properties of ATG. ATGs are associated with improved allograft survival without rejection in patients at high immunological risk and are therefore indicated as first-line therapy in this population. In patients at low immunological risk, anti-CD25 monoclonal antibodies (anti-CD25mAb) are recommended as first-line therapy because ATGs are associated with a higher incidence of infections despite their equivalent efficacy in this population compared to anti-CD25mAb. However, neither the dosages nor the treatment duration of ATGs are clearly defined (recommended Grafalon® dosages range from 5 to 2 mg/kg/day for 5 to 21 days) and ATGs remain widely prescribed to allow early withdrawal of corticosteroids. Determination of optimal non-depleting doses of ATG could be of great interest because, in vitro, ATG is able to induce regulatory polarization of naïve T cells even at non-depleting doses. Thus, the use of such doses in patients with low immunological risk may be of interest in clinical practice with respect to anti-CD25mAb, particularly for their pro-regulatory properties and their low cost. This question must be clearly addressed in a pilot clinical study.
The purpose of this study is to find the optimal non-depleting dose (Maximum Tolerated Dose; MTD) of rabbit anti-human T-lymphocyte immunoglobulin (Grafalon®) to prevent the complications associated with prolonged CD4 T cell lymphopenia in low immunological risk renal transplant recipients. The primary outcome for the de-escalation study is the Dose Limiting Toxicity (DLT) defined by a T cell (CD3+) relative depletion above 30 % compared to baseline (Day 0) at the end of the Grafalon® induction treatment (Day 4).
The patients under study are adult receiving first kidney transplantation without a high immunological risk of rejection (african-American ethnicity, presence of a donor-specific antibody, blood group incompatibility, delayed onset of graft function (i.e donor after cardiac death), cold ischemia time >24 hours, anti-HLA immunization (Flow PRA > or = 20%, presence of donor specific antibody before and/or at time of transplantation and with a positive CDC and FXM with historical and/or transplant day sera), bacterial, viral or mycotic and parasitic infections, history of opportunistic infection that required intensive care hospitalization in the two years preceding the transplant, related donor with two-haplotype HLA matched kidneys, multi-organ transplant, history of cancer, thrombocytopenia < 50 000 platelets/µl, hypersensitivity to the active substance or to the excipients of Grafalon (monosodium phosphate dihydrate, phosphoric acid).
The inclusion period is one year. According to the active file of the center of Besançon, it is planned to include 2 patients per month. The maximum number of patients to include is 18. With a margin of error of 20%, it is possible to include all patients in 1 year. The duration of patient participation in the study is 1 year (one-year follow-up). Consequently, the duration of the study is estimated at 2 years (1 year of inclusion and 1 year of follow-up).
ODORAT is a monocenter, open-label, de-escalation phase1b controlled study. The study will be proposed to patients receiving a first kidney transplant and matching the criteria of inclusion. Recruitment will be achieved only in Besançon's transplant unit. The physician gives information on the study and collect informed consent. Then the treatment is assigned according to the dose determined by the dose de-escalation study. The first dose tested is the dose level at 2 mg/kg/day (level 3). This dose is the reference dose according to the current recommendations. The number of patients included at each dose is determined according to Bayesian optimal interval (BOIN) design.
The administration of treatment begin at time of transplantation according to recommendation.
The study will include 11 visits: D0 (baseline) to D4 (primary end point assessement), D7, D14, M1, M3, M6 and M12, to analyze pharmacokinetics of Grafalon and the immune phenotype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The number of patients included at each dose is determined according to Bayesian optimal interval (BOIN) design.
| Arm | Type | Receives |
|---|---|---|
| Group 3 : 2 mg/kg/j | Experimental | Drug: Grafalon® administered during 5 consecutive days at 2 mg/kg/jGroup 3 receives treatment in accordance with health recommendations as part of prophylactic treatment for acute rejection after allogeneic solid organ transplantation, at the minimum dose, i.e., 2 to 5 mg/kg/day for 5 to 21 days. |
| Group 2 : 1 mg/kg/j | Experimental | Drug: Grafalon® administered during 5 consecutive days at 1 mg/kg/jGroup 2 receive treatment at lower doses than the recommended dose for the same duration (5 days). |
| Group 1 : 0,5 mg/kg/j | Experimental | Drug: Grafalon® administered during 5 consecutive days at 0,5 mg/kg/jGroup 1 receive treatment at lower doses than the recommended dose for the same duration (5 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Females must be using highly effective contraceptive measures (see Section V-9), and have a negative pregnancy test prior to the start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening :
- Patient affiliated to or beneficiary of French social security system
- Signed and dates informed consent
- Patient receiving first kidney transplantation
Key exclusion criteria (18 listed)
- Current participation in a study of an investigational agent or in the period of exclusion
- Pregnant or breast-feeding subjects,
- Patient under guardianship, curatorship or under the protection of justice
- Subject not able to cooperate properly in the study judged by the investigator.
- Patients with bacterial, viral or mycotic and parasitic infections,History of opportunistic infection that required intensive care hospitalization in the two years preceding the transplant
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 |
|---|---|---|
| Grafalon® administered during 5 consecutive days at 2 mg/kg/jAlso: Group 3This de-escalation study was planned to investigate 3 doses level of Grafalon® administered during 5 consecutive days, i.e.: Group 3 : 2 mg/kg/j, Group 2 : 1 mg/kg/j, Group 1 : 0,5 mg/kg/j. Group 3 receives treatment in accordance with health recommendations as part of prophylactic treatment for acute rejection after allogeneic solid organ transplantation, at the minimum dose, i.e., 2 to 5 mg/kg/day for 5 to 21 days. | Drug | Group 3 : 2 mg/kg/j |
| Grafalon® administered during 5 consecutive days at 1 mg/kg/jAlso: Group 2This de-escalation study was planned to investigate 3 doses level of Grafalon® administered during 5 consecutive days, i.e.: Group 3 : 2 mg/kg/j, Group 2 : 1 mg/kg/j, Group 1 : 0,5 mg/kg/j. Group 2 receive treatment at lower doses than the recommended dose for the same duration (5 days). Treatment begins on the day of transplantation immediately before the procedure at induction of sedation. | Drug | Group 2 : 1 mg/kg/j |
| Grafalon® administered during 5 consecutive days at 0,5 mg/kg/jAlso: Group 1This de-escalation study was planned to investigate 3 doses level of Grafalon® administered during 5 consecutive days, i.e.: Group 3 : 2 mg/kg/j, Group 2 : 1 mg/kg/j, Group 1 : 0,5 mg/kg/j. Group 1 receive treatment at lower doses than the recommended dose for the same duration (5 days). Treatment begins on the day of transplantation immediately before the procedure at induction of sedation | Drug | Group 1 : 0,5 mg/kg/j |
Primary outcome
The optimal non-depleting dose (Maximum Tolerated Dose; MTD) of rabbit anti-human T-lymphocyte immunoglobulin (Grafalon®) to prevent the complications associated with prolonged CD4 T cell lymphopenia in low immunological risk renal transplant recipients.
Time frame: From transplantation to the end of treatment at 4 days
The Dose Limiting Toxicity (DLT) defined by a T cell (CD3+) relative depletion above 30 % compared to baseline (Day 0) at the end of the Grafalon® induction treatment (Day 4).
8 secondary outcomes
The tolerance of Grafalon® in each dose level.
Time frame: From transplantation to the end of the study at 1 year.
Clearance of Grafalon® during the treatment period and until month-3 in each dose level.
Time frame: From transplantation to 3 month after first treatment.
Describe immune profile and immune restauration in each dose level.
Time frame: From transplantation to 1 year after.
Describe time to event clinical endpoints since transplantation at each dose level.
Time frame: From transplation to 1 year after.
The rate of patients with infection up to 1 year after transplantation in each dose level.
Time frame: From transplantation to 1 year after
The number of infections by patients up to 1 year after transplantation in each dose level
Time frame: From transplantation to 1 year after
The rate of patients with an atherosclerotic event up to 1 year after transplantation in each dose level
Time frame: From transplantation to year after
Renal function at 1 year post transplant in each dose level
Time frame: From transplantation to 1 year after.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Grafalon® administered during 5 consecutive days at 2 mg/kg/j, Grafalon® administered during 5 consecutive days at 1 mg/kg/j and Grafalon® administered during 5 consecutive days at 0,5 mg/kg/j in people with Renal Transplantation, run by Centre Hospitalier Universitaire de Besancon.
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 9 inclusion and 18 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: opening soon, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamal Bamoulid, MD, PHD (+33381219221, jbamoulid@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The optimal non-depleting dose (Maximum Tolerated Dose; MTD) of rabbit anti-human T-lymphocyte immunoglobulin (Grafalon®) to prevent the complications associated with prolonged CD4 T cell lymphopenia in low immunological risk renal transplant recipients. (time frame: From transplantation to the end of treatment at 4 days). 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 20 Dec 2024.