Renal Transplant RejectionPhase 2RIMININCT04114188
Tacrolimus After rATG and Infliximab Induction Immunosuppression (RIMINI)
A Phase 2 study testing Antithymocyte Immunoglobulin (Rabbit) in people with Renal Transplant Rejection, run by Prof. Dr. Petra Reinke at 1 site in Germany.
Trial summary
International multicenter open-label single-arm confidence-interval-estimation based Phase II clinical trial, aiming to estimate a plausible range of the proportion of patients experiencing efficacy failure in the population, to provide evidence for efficacy and safety of the induction regimen with rATG and infliximab… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Transplant Rejection
- What is being tested?
- Antithymocyte Immunoglobulin (Rabbit)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- 15 Dec 2016to 31 Dec 2020
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary deceased-donor or living-donor kidney transplantation XML File Identifier: CJub4EkHas0e/mXDp2mGyZzEe9E= Page 22/33
- Men and women (recipient) age >18 years and <70 years
- Panel reactive antibody frequency/ calculated panel reactive antibody frequency (peak PRA/cPRA) <20%
- Written informed consent
- Diagnosis of end stage renal disease
- 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) within 72 hours prior to the start of clinical trial. Male participants with pregnant or nonpregnant WOCBP partner must use condoms.
Who cannot join
- Previous transplantation
- Combined kidney transplantation with other organ
- Subjects receiving an allograft from a donor older than 65 years with elevated serum creatinine levels and/or treated diabetes.
- Immunosuppressive therapy up to 6 months before transplantation
- Planned induction therapy with depletion agents
- EBV seronegativity
Show all 27Show fewer
- HIV positivity
- Leukopenia < 3000 cells per microliter, thrombocytopenia < 100 000 cells per microliter
- Biological therapy history with ATG, OKT3, anti TNF agents
- Tuberculosis history
- Cancer history (skin non-melanoma cancer excluded)
- Anti HCV positivity, HBsAg positivity or HBV DNA positivity
- Detectable donor specific antibodies (DSA) by solid phase assay (Luminex®)
- 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
- All contraindications against study medication (including auxiliary substances)
- Interactions with study medication
- Current treatment with one of the following substances:
- cyclosporine, tacrolimus, mycophenolate mofetil, azathioprine, rituximab, prednisone
- Patients unwilling to consent to saving and propagation of pseudonymized medical data and/or biological samples for study reasons
- Chronic heart failure (NYHA III, IV) at transplantation
- Participation in other clinical trials (pharmaceutical trials)
- persons dependent of the sponsor, investigator or investigative site
- positive Quantiferon test (for TBC)
- live vaccine treatment 30 days prior to enrolment in this clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
International multicenter open-label single-arm confidence-interval-estimation based Phase II clinical trial, aiming to estimate a plausible range of the proportion of patients experiencing efficacy failure in the population, to provide evidence for efficacy and safety of the induction regimen with rATG and infliximab and a go/no go rule for further clinical development.
Read the detailed description
A total of 75 patients will receive the proposed induction regimen, with expected 68 completers accounting for drop-outs and non-compliances with the protocol. If up to 27 out of the 68 completers experience efficacy failure, a progression into a larger trial will be considered justifiable. If the number of patients experiencing efficacy failure is between 28 and 34 out of 68, the merits of a larger non-inferiority design will be considered depending on the risk/benefit assessment. If more than 34 out of the 68 completers experience efficacy failure, a progression into a larger trial would be considered unjustifiable. 1st kidney transplant recipients (low risk: PRA/cPRA < 20%, no DSA) will receive short rATG induction (2x1.5 mg/kg) given perioperatively and on first postoperative day. All patients will receive one shot Infliximab mAb at day 2. Since POD1, maintenance IS consists of Tac and tapered steroids therapy. All patients will be followed up for one year.
At the POD 0 the first rATG dose (1.5mg/kg) will be given according to the local practice and Methyprednisolon 500mg will be given before reperfusion. At the POD 1 patients will receive methylprednisolon 500mg i.v. followed by second rATG dose (1.5mg/kg). Infliximab 5mg/kg b.w. will be given in slow infusion on POD2. Tacrolimus will be given the first dose before surgery at dose 0.1 mg/kg and next from POD1 at 0.2mg/kg/day and doses adjusted according to blood trough levels (10-15 ng/mL, POD1-POD13, 5-8ng/mL POD 14-90, 4-6ng/mL POD >90. Prednison (or appropriate dose of methylprednisolone) will be initiated POD 2 at a dose of 20mg/day and slowly tapered down to 5 mg at the POD 7 (POD2: 20mg, POD3: 15mg, POD4-5: 10mg, POD6-7: 7,5mg, > POD7: 5mg).
- Conditions
- Renal Transplant Rejection
- Being tested
- Antithymocyte Immunoglobulin (Rabbit)
- Keywords
- transplant medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithymocyte Immunoglobulin (Rabbit)Drug
Also called Infliximab, Tacrolimus, Prednisolone
1st kidney transplant recipients (low risk: PRA/cPRA < 20%, no DSA) will receive short rATG induction (2x1.5 mg/kg) given perioperatively and on first postoperative day. All patients will receive one shot Infliximab mAb at day 2. Since POD1, maintenance IS consists of Tac and tapered steroids therapy.
| Study group | Role | What they receive |
|---|---|---|
| Antithymocyte Immunoglobulin (Rabbit) | Experimental | rATG induction on day 0 \& 1 post op Receives: Drug: Antithymocyte Immunoglobulin (Rabbit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of efficacy failure [(treated biopsy-proven acute rejection, graft loss, death, or loss to follow-up) and renal function (estimated glomerular filtration rate)] of the induction regimen
Composite endpoint of efficacy failure of the induction regimen defined as occurrence of any of the following individual outcomes up to 12 months post transplantation (start of follow up at transplantation): acute rejection, graft loss or poor graft function defined as eGFR<40 ml/min.
Measured: 12 months post transplantation
Secondary outcomes (12)
Prevalence of biomarker signatures at 6, 12 months of follow-up.
The following biomarker analyses are implemented in the trial:
- ELISpot/CTLp
- EBV/CMV/BKV load + CMV/EBV T-Ly
- Multi-parameter flow cytometry
- gene expression profiling
- alloantibodies
- urinary IP-10
- HO-1 polymorphisms
- histology (protocol/induced biopsies)
Measured: 6, 12 months of follow-up
Incidence of death by 12 months post-transplantation
incidence of death by 12 month post transplantation
Measured: 12 months post-transplantation
Incidence of graft loss by 12 months post-transplantation
Incidence of graft loss by 12 months post-transplantation
Measured: 12 months post-transplantation
Incidence of metabolic and cardiovascular co-morbidity by 12 months post-transplantation
Incidence of metabolic and cardiovascular co-morbidity by 12 months post-transplantation (post-transplant diabetes mellitus, dyslipidemia, hypertension, myocardial infarction, stroke, peripheral vascular disease)
Measured: 12 months post-transplantation
Proportion of subjects who remain on tacrolimus/steroids therapy at 12 months post-transplantation
Proportion of subjects who remain on tacrolimus/steroids therapy at 12 months post-transplantation
Measured: 12 months post-transplantation
Incidence of acute and chronic lesions assessed by the Banff 07 score in protocol biopsy at 12months post-transplantation
Banff classification:
- Normal
- Antibody mediated rejection
- Borderline
- T cell mediated rejection:
Type IA: cases with significant interstitial infiltration (> 25% of parenchyma affected, i2 or i3) \& foci of moderate tubulitis (t2) Type IB: cases with significant interstitial infiltration (> 25% of parenchyma affected, i2 or i3) \& foci of severe tubulitis (t3) Type IIA: cases with mild to moderate intimal arteritis (v1) Type IIB: cases with severe intimal arteritis comprising > 25% of luminal area (v2) Type III: cases with transmural arteritis or arterial fibrinoid change \& necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3) Chronic allograft arteriopathy
- Interstitial fibrosis and tubular atrophy: Grade I: mild interstitial fibrosis \& tubular atrophy Grade II: moderate interstitial fibrosis \& tubular atrophy Grade III: severe interstitial fibrosis \& tubular atrophy/loss
Measured: 12 months post-transplantation
Incidence of discontinuation of study treatment
Incidence of discontinuation of study treatment
Measured: 12 month
Donor specific antibody (DSA) at 12M
Assessment of donor specific antibody at 12M Method of assessment: Luminex assay
Measured: 12 months post-transplantation
Overall safety of tacrolimus/steroids therapy immunosuppressive regimen measured by the occurrence of viral and bacterial infections, malignancies and autoimmunity.
Overall safety of tacrolimus/steroids therapy immunosuppressive regimen measured by the occurrence of viral and bacterial infections, malignancies and autoimmunity
Measured: 12 month
Health-related quality of life using SF-36v2 questionnaires at baseline (pre Transplantation), Month 1, Month 3, Month 6, and Month 12
The SF-36v2 provides scores for each of the eight health domains and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health
Measured: baseline (pre transplantation), Month 1, Month 3, Month 6, and Month12
Assessment of patient-specific resource consumption using a trial specific questionnaire at initial discharge, Month 3, Month 6, Month 12, and in cases of repeated hospitalization
The questionnaires capture relevant apsects of resource consumption:
- In which ward(s) a patient was hospitalized
- Additional services (diagnostics / procedures / operations)
- Potential dialysis procedures (past and expected frequency in the future)
- Potential outpatient visits and the services consumed
- Employment status and potential depency on care-giving The completion requires a review of inpatient records. Part II and Part III also require a short interview with the patient about potential outpatient visits during the study period, their employment status, and potential depedency on care-giving.
Measured: initial discharge, Month 3, Month 6, Month 12, and in cases of repeated hospitalization
Health-related quality of life using EQ5D-5L questionnaires at baseline (pre Transplantation), Month 1, Month 3, Month 6, and Month 12
EQ-5D is a standardized instrument for measuring generic health status. It has been widely used in population health surveys, clinical studies, economic evaluation and in routine outcome measurement in the delivery of operational healthcare.
The EQ-5D-5L is a Patient Reported Outcome (PRO) instrument that can generally assess the quality of life of patients, regardless of their disease, over 6 questions. It also includes a vertical EQ visual analog scale (EQ VAS, 0-100 points) and a descriptive EQ-5D-5L system, which considers the following 5 dimensions or subscales over 5 levels or possible answers.
dimensions: mobility, self-sufficiency, General Activities, Pain / Physical complaints, fear / dejectedness levels: Level 1: No problems/ No pain/ Not afraid; Level 2: Slight problems/ Slight pain/ A little anxious; Level 3: Moderate problems/ Moderate pain/ Moderate anxiety; Level 4: Major problems / Severe pain/ Very anxious; Level 5: Not able to/ Extreme pain/ Extremely anxious
Measured: baseline (pre transplantation), Month 1, Month 3, Month 6, and Month12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start15 Dec 2016
- Primary completionDec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Transplant RejectionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a confidence-interval-estimation based early phase design, aiming to estimate a plausible range of the population treatment effect which is not bound to a formal hypothesis.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Petra Reinke
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Klinické a Experimentální Medicíny
- Responsible party
- Sponsor-investigator, Prof. Dr. Petra Reinke, Charite University, Berlin, Germany
- Investigators
- Reinke Reinke, PhD, MD, Study chair, Charité-University Medicine (Berlin, Germany)Ondrej Viklicky, PhD, MD, Principal investigator, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114188
- Sponsor's protocol ID
- RIMINI
- Acronym
- RIMINI
- Status last verified
- Jan 2021
- First submitted
- 15 Oct 2018
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Viklicky O, Zahradka I, Bold G, Bestard O, Hruba P, Otto NM, Stein M, Sefrin A, Modos I, Meneghini M, Crespo E, Grinyo J, Volk HD, Christakoudi S, Reinke P. Tacrolimus After rATG and Infliximab Induction Immunosuppression-RIMINI Trial. Transplantation. 2024 Jan 1;108(1):242-251. doi: 10.1097/TP.0000000000004736. Epub 2023 Aug 1.
PubMed 37525369
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tacrolimus After rATG and Infliximab Induction Immunosuppression (RIMINI)
- ClinicalTrials.gov ID
- NCT04114188
- Acronym / sponsor ID
- RIMINI / RIMINI
- Conditions
- Renal Transplant Rejection
- Keywords
- transplant medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Prof. Dr. Petra ReinkeUniversity, hospital or other
- Collaborators
- Institut Klinické a Experimentální Medicíny
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 3 Oct 2019 (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.
International multicenter open-label single-arm confidence-interval-estimation based Phase II clinical trial, aiming to estimate a plausible range of the proportion of patients experiencing efficacy failure in the population, to provide evidence for efficacy and safety of the induction regimen with rATG and infliximab and a go/no go rule for further clinical development.
Detailed description
A total of 75 patients will receive the proposed induction regimen, with expected 68 completers accounting for drop-outs and non-compliances with the protocol. If up to 27 out of the 68 completers experience efficacy failure, a progression into a larger trial will be considered justifiable. If the number of patients experiencing efficacy failure is between 28 and 34 out of 68, the merits of a larger non-inferiority design will be considered depending on the risk/benefit assessment. If more than 34 out of the 68 completers experience efficacy failure, a progression into a larger trial would be considered unjustifiable. 1st kidney transplant recipients (low risk: PRA/cPRA < 20%, no DSA) will receive short rATG induction (2x1.5 mg/kg) given perioperatively and on first postoperative day. All patients will receive one shot Infliximab mAb at day 2. Since POD1, maintenance IS consists of Tac and tapered steroids therapy. All patients will be followed up for one year.
At the POD 0 the first rATG dose (1.5mg/kg) will be given according to the local practice and Methyprednisolon 500mg will be given before reperfusion. At the POD 1 patients will receive methylprednisolon 500mg i.v. followed by second rATG dose (1.5mg/kg). Infliximab 5mg/kg b.w. will be given in slow infusion on POD2. Tacrolimus will be given the first dose before surgery at dose 0.1 mg/kg and next from POD1 at 0.2mg/kg/day and doses adjusted according to blood trough levels (10-15 ng/mL, POD1-POD13, 5-8ng/mL POD 14-90, 4-6ng/mL POD >90. Prednison (or appropriate dose of methylprednisolone) will be initiated POD 2 at a dose of 20mg/day and slowly tapered down to 5 mg at the POD 7 (POD2: 20mg, POD3: 15mg, POD4-5: 10mg, POD6-7: 7,5mg, > POD7: 5mg).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a confidence-interval-estimation based early phase design, aiming to estimate a plausible range of the population treatment effect which is not bound to a formal hypothesis.
| Arm | Type | Receives |
|---|---|---|
| Antithymocyte Immunoglobulin (Rabbit) | Experimental | Drug: Antithymocyte Immunoglobulin (Rabbit)rATG induction on day 0 \& 1 post op |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary deceased-donor or living-donor kidney transplantation XML File Identifier: CJub4EkHas0e/mXDp2mGyZzEe9E= Page 22/33
- Men and women (recipient) age >18 years and <70 years
- Panel reactive antibody frequency/ calculated panel reactive antibody frequency (peak PRA/cPRA) <20%
- Written informed consent
- Diagnosis of end stage renal disease
Key exclusion criteria (27 listed)
- Previous transplantation
- Combined kidney transplantation with other organ
- Subjects receiving an allograft from a donor older than 65 years with elevated serum creatinine levels and/or treated diabetes.
- Immunosuppressive therapy up to 6 months before transplantation
- Planned induction therapy with depletion agents
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 |
|---|---|---|
| Antithymocyte Immunoglobulin (Rabbit)Also: Infliximab, Tacrolimus, Prednisolone1st kidney transplant recipients (low risk: PRA/cPRA < 20%, no DSA) will receive short rATG induction (2x1.5 mg/kg) given perioperatively and on first postoperative day. All patients will receive one shot Infliximab mAb at day 2. Since POD1, maintenance IS consists of Tac and tapered steroids therapy. | Drug | Antithymocyte Immunoglobulin (Rabbit) |
Primary outcome
Composite endpoint of efficacy failure [(treated biopsy-proven acute rejection, graft loss, death, or loss to follow-up) and renal function (estimated glomerular filtration rate)] of the induction regimen
Time frame: 12 months post transplantation
Composite endpoint of efficacy failure of the induction regimen defined as occurrence of any of the following individual outcomes up to 12 months post transplantation (start of follow up at transplantation): acute rejection, graft loss or poor graft function defined as eGFR<40 ml/min.
12 secondary outcomes
Prevalence of biomarker signatures at 6, 12 months of follow-up.
Time frame: 6, 12 months of follow-up
Incidence of death by 12 months post-transplantation
Time frame: 12 months post-transplantation
Incidence of graft loss by 12 months post-transplantation
Time frame: 12 months post-transplantation
Incidence of metabolic and cardiovascular co-morbidity by 12 months post-transplantation
Time frame: 12 months post-transplantation
Proportion of subjects who remain on tacrolimus/steroids therapy at 12 months post-transplantation
Time frame: 12 months post-transplantation
Incidence of acute and chronic lesions assessed by the Banff 07 score in protocol biopsy at 12months post-transplantation
Time frame: 12 months post-transplantation
Incidence of discontinuation of study treatment
Time frame: 12 month
Donor specific antibody (DSA) at 12M
Time frame: 12 months post-transplantation
Overall safety of tacrolimus/steroids therapy immunosuppressive regimen measured by the occurrence of viral and bacterial infections, malignancies and autoimmunity.
Time frame: 12 month
Health-related quality of life using SF-36v2 questionnaires at baseline (pre Transplantation), Month 1, Month 3, Month 6, and Month 12
Time frame: baseline (pre transplantation), Month 1, Month 3, Month 6, and Month12
Assessment of patient-specific resource consumption using a trial specific questionnaire at initial discharge, Month 3, Month 6, Month 12, and in cases of repeated hospitalization
Time frame: initial discharge, Month 3, Month 6, Month 12, and in cases of repeated hospitalization
Health-related quality of life using EQ5D-5L questionnaires at baseline (pre Transplantation), Month 1, Month 3, Month 6, and Month 12
Time frame: baseline (pre transplantation), Month 1, Month 3, Month 6, and Month12
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 29 Jan 2021.
- Derived from this study: PubMed 37525369Viklicky O, Zahradka I, Bold G, Bestard O, Hruba P, Otto NM, Stein M, Sefrin A, Modos I, Meneghini M, Crespo E, Grinyo J, Volk HD, Christakoudi S, Reinke P. Tacrolimus After rATG and Infliximab Induction Immunosuppression-RIMINI Trial. Transplantation. 2024 Jan 1;108(1):242-251. doi: 10.1097/TP.0000000000004736. Epub 2023 Aug 1.
- 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. This study is not recruiting at the moment.
Reinke Reinke, PhD, MD study chair
Charité-University Medicine (Berlin, Germany)
Ondrej Viklicky, PhD, MD principal investigator
Institute for Clinical and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antithymocyte Immunoglobulin (Rabbit) in people with Renal Transplant Rejection, run by Prof. Dr. Petra Reinke at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 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 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of efficacy failure [(treated biopsy-proven acute rejection, graft loss, death, or loss to follow-up) and renal function (estimated glomerular filtration rate)] of the induction regimen (time frame: 12 months post transplantation). 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 NCT04114188, which also lists 1 linked publication.
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 29 Jan 2021.