Kidney Transplant RejectionROSETTENCT06100965
Reduced-dose Alemtuzumab for Kidney Transplant Rejection
An observational study of Kidney Transplant Rejection, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Prospective, follow-up study of kidney transplant recipients treated with alemtuzumab anti-rejection therapy for severe or glucocorticoid-resistant kidney transplant rejection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2023to 1 Jul 2026
- Phase
- Observational
- 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
Study population: Kidney transplant recipients who experience severe or glucocorticoid-resistant rejection of their allograft.
Who may be able to join
- 18 years or older
- Treatment for severe or glucocorticoid-resistant kidney transplant rejection with alemtuzumab.
Who cannot join
- Treatment with a different lymphocyte depleting agent (e.g. rATG) prior to treatment with alemtuzumab for the same rejection episode.
- Recipients who have T cell counts below 200 × 106/L before the start of therapy (for instance, because of lymphocyte depleting induction therapies).
- Inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015 GD
Lukas K van Vugt, Drs., 0031 10 704 0704, l.k.vanvugt@erasmusmc.nl
About this study
Official title: The Effects of Reduced Dose Alemtuzumab for Severe Kidney Transplant Rejection
Prospective, follow-up study of kidney transplant recipients treated with alemtuzumab anti-rejection therapy for severe or glucocorticoid-resistant kidney transplant rejection.
Read the detailed description
Study design: Prospective observational cohort study. Study population: Adult patients who are treated with alemtuzumab for severe or glucocorticoid-resistant kidney transplant rejection.
Intervention (if applicable): Not applicable. Main study parameters/endpoints: Lymphocyte (subtype) repopulation, serious infections, one-year graft survival, alemtuzumab plasma levels, intra-cellular signalling of repopulated T and B cells, cytokine-levels, donor-specificity of repopulated T cells, differences pre- and post-treatment of donor-derived cell-free DNA, plasma nucleosomes, urinary chemokines, urinary extracellular vesicles, breath-pattern analysis.
- Conditions
- Kidney Transplant Rejection
- Keywords
- alemtuzumab
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with lymphocyte repopulation
Outcome reporting of the proportion of patients that has repopulation of T and B lymphocytes, defined as cell counts of >200 10E6/L for T lymphocytes and > 100 10E6/L for B lymphocytes.
Measured: 6 months and 1 year
Secondary outcomes (3)
Cumulative incidence of graft loss
Cumulative incidence of graft loss at specified time-points with death as competing risk, computed by cumulative incidence functions.
Measured: 6 months, 1 year
Serious infections
Necessitating hospital admission, or hospital-acquired
Measured: 6 months, 1 year
Patient survival
Proportion of patients who survived at specified time-points, computed with kaplan-meier estimates at specified time-points.
Measured: 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Dec 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas K. van Vugt, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100965
- Sponsor's protocol ID
- NL82152.078.23
- Acronym
- ROSETTE
- Status last verified
- Feb 2024
- First submitted
- 20 Oct 2023
- Last updated
- 21 Feb 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 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Reduced Dose Alemtuzumab for Severe Kidney Transplant Rejection
- ClinicalTrials.gov ID
- NCT06100965
- Acronym / sponsor ID
- ROSETTE / NL82152.078.23
- Conditions
- Kidney Transplant Rejection
- Keywords
- alemtuzumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 25 Oct 2023 (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.
Prospective, follow-up study of kidney transplant recipients treated with alemtuzumab anti-rejection therapy for severe or glucocorticoid-resistant kidney transplant rejection.
Detailed description
Study design: Prospective observational cohort study. Study population: Adult patients who are treated with alemtuzumab for severe or glucocorticoid-resistant kidney transplant rejection.
Intervention (if applicable): Not applicable. Main study parameters/endpoints: Lymphocyte (subtype) repopulation, serious infections, one-year graft survival, alemtuzumab plasma levels, intra-cellular signalling of repopulated T and B cells, cytokine-levels, donor-specificity of repopulated T cells, differences pre- and post-treatment of donor-derived cell-free DNA, plasma nucleosomes, urinary chemokines, urinary extracellular vesicles, breath-pattern analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients who experience severe or glucocorticoid-resistant rejection of their allograft.
Key inclusion criteria (2 listed)
- 18 years or older
- Treatment for severe or glucocorticoid-resistant kidney transplant rejection with alemtuzumab.
Key exclusion criteria (3 listed)
- Treatment with a different lymphocyte depleting agent (e.g. rATG) prior to treatment with alemtuzumab for the same rejection episode.
- Recipients who have T cell counts below 200 × 106/L before the start of therapy (for instance, because of lymphocyte depleting induction therapies).
- Inability to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with lymphocyte repopulation
Time frame: 6 months and 1 year
Outcome reporting of the proportion of patients that has repopulation of T and B lymphocytes, defined as cell counts of >200 10E6/L for T lymphocytes and > 100 10E6/L for B lymphocytes.
3 secondary outcomes
Cumulative incidence of graft loss
Time frame: 6 months, 1 year
Serious infections
Time frame: 6 months, 1 year
Patient survival
Time frame: 6 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Rejection, run by Erasmus Medical Center at 1 site in Netherlands.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukas K van Vugt, Drs. (0031 10 704 0704, l.k.vanvugt@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with lymphocyte repopulation (time frame: 6 months and 1 year). 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 21 Feb 2024.