Renal TransplantPhase 4PK-rituximabNCT00820469
Study of the Influence of Plasma Exchange on the Pharmacokinetics of Rituximab
A Phase 4 study testing Rituximab 375 and rituximab 1000 in people with Renal Transplant and Autoimmune Diseases, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Rituximab (a monoclonal antibody raised against CD20) is used to treat various immune disorders. In some cases such as treatment of humoral acute rejection of renal transplant, thrombotic thrombocytopenic purpura, vasculitis or cryoglobulinemia, rituximab is often associated with plasma exchange. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant, Autoimmune Diseases
- What is being tested?
- Rituximab 375 and rituximab 1000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Jan 2010
- Phase
- Phase 4
- 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
- Patient who should be treated by rituximab for various autoimmune diseases or humoral acute rejection of renal transplant
- Patient older than 18 years old
- Patient who have signed the written informed consent form
Who cannot join
- Patient presenting a contra indication to rituximab (hypersensitivity, active infection, severe cardiac failure (NYHA class IV))
- Blood sampling impossibility
- Pregnant or breasting women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Plasma Exchange Therapy on the Pharmacokinetics of Rituximab in Patients Treated for Autoimmune Disorders.
Rituximab (a monoclonal antibody raised against CD20) is used to treat various immune disorders. In some cases such as treatment of humoral acute rejection of renal transplant, thrombotic thrombocytopenic purpura, vasculitis or cryoglobulinemia, rituximab is often associated with plasma exchange. The pharmacokinetic of the rituximab can be affected by plasma exchange but the knowledge is poor in this matter.
The aim of the study is to explore the influence of plasma exchange on the pharmacokinetic of rituximab.
The results of this study should conclude if plasma exchange leads to a significant decrease of plasma concentration of rituximab or not, and if the decreased of the concentration is associated with a decrease in efficacy.
Read the detailed description
Twenty patients will be enrolled: ten patients treated by rituximab and ten patients treated by rituximab and plasma exchange. The plasma concentration of rituximab and the efficacy of the treatment will be compared between the two groups of patients.
The enrollment in the study will not change the treatment of patients except for blood sampling.
Each patient will undergo fifteen blood samples between the start of infusion of rituximab and three months after the start of infusion. For the patients who will undergo plasma exchange, three additional blood samples will be performed at each plasma exchange (at the start, at the end and one day after the plasma exchange) and a sample of the plasma exchanged will be keep.
The plasma concentration of rituximab will be determined by ELISA method (Enzyme Linked ImmunoSorbent Assay) The pharmacokinetic analyse will consist in the determination of the Area Under the Concentration Curve (AUC) by a non compartmental approach.
The AUC levels will be compared (using the t Student test) between the two populations of patients (patients treated by rituximab, versus patients treated by rituximab and plasma exchange) The efficacy of the treatment will be evaluated by the CD19+ B Cell count.
- Conditions
- Renal Transplant, Autoimmune Diseases
- Being tested
- Rituximab 375, rituximab 1000
- Keywords
- Rituximab, Plasma exchange, Autoimmune diseases
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab 375Drug
rituximab 375 mg/m2 IV weekly, during 4 weeks
rituximab 1000Drug
rituximab 1000 mg IV, two infusions on day 1 and day 15
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients treated by rituximab Receives: Drug: Rituximab 375 |
| 2 | Experimental | Patients treated by rituximab and plasma exchange Receives: Drug: rituximab 1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the total AUC levels between 2 arms : patients treated by rituximab alone or patients treated by rituximab and plasma exchange
Measured: Determination on the overall plasma concentration profile between the start of infusion and three months after the start of infusion
Secondary outcomes (2)
Determination of amount rituximab eliminated during a plasma exchange
Measured: At each plasma exchange
Evaluation of the efficacy of the treatment by CD19+B Cell count
Measured: 15 dyas, 1, 2, 3, 6 and 9 months after rituximab infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startSep 2008
- Primary completionNov 2009
- Study completionJan 2010
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 TransplantStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Pourrat, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820469
- Sponsor's protocol ID
- 07 140 03
- Acronym
- PK-rituximab
- Status last verified
- May 2017
- First submitted
- 9 Jan 2009
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Puisset F, White-Koning M, Kamar N, Huart A, Haberer F, Blasco H, Le Guellec C, Lafont T, Grand A, Rostaing L, Chatelut E, Pourrat J. Population pharmacokinetics of rituximab with or without plasmapheresis in kidney patients with antibody-mediated disease. Br J Clin Pharmacol. 2013 Nov;76(5):734-40. doi: 10.1111/bcp.12098.
PubMed 23432476
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Plasma Exchange Therapy on the Pharmacokinetics of Rituximab in Patients Treated for Autoimmune Disorders.
- ClinicalTrials.gov ID
- NCT00820469
- Acronym / sponsor ID
- PK-rituximab / 07 140 03
- Conditions
- Renal Transplant, Autoimmune Diseases
- Keywords
- Rituximab, Plasma exchange, Autoimmune diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 12 Jan 2009 (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.
Rituximab (a monoclonal antibody raised against CD20) is used to treat various immune disorders. In some cases such as treatment of humoral acute rejection of renal transplant, thrombotic thrombocytopenic purpura, vasculitis or cryoglobulinemia, rituximab is often associated with plasma exchange. The pharmacokinetic of the rituximab can be affected by plasma exchange but the knowledge is poor in this matter.
The aim of the study is to explore the influence of plasma exchange on the pharmacokinetic of rituximab.
The results of this study should conclude if plasma exchange leads to a significant decrease of plasma concentration of rituximab or not, and if the decreased of the concentration is associated with a decrease in efficacy.
Detailed description
Twenty patients will be enrolled: ten patients treated by rituximab and ten patients treated by rituximab and plasma exchange. The plasma concentration of rituximab and the efficacy of the treatment will be compared between the two groups of patients.
The enrollment in the study will not change the treatment of patients except for blood sampling.
Each patient will undergo fifteen blood samples between the start of infusion of rituximab and three months after the start of infusion. For the patients who will undergo plasma exchange, three additional blood samples will be performed at each plasma exchange (at the start, at the end and one day after the plasma exchange) and a sample of the plasma exchanged will be keep.
The plasma concentration of rituximab will be determined by ELISA method (Enzyme Linked ImmunoSorbent Assay) The pharmacokinetic analyse will consist in the determination of the Area Under the Concentration Curve (AUC) by a non compartmental approach.
The AUC levels will be compared (using the t Student test) between the two populations of patients (patients treated by rituximab, versus patients treated by rituximab and plasma exchange) The efficacy of the treatment will be evaluated by the CD19+ B Cell count.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rituximab 375Patients treated by rituximab |
| 2 | Experimental | Drug: rituximab 1000Patients treated by rituximab and plasma exchange |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient who should be treated by rituximab for various autoimmune diseases or humoral acute rejection of renal transplant
- Patient older than 18 years old
- Patient who have signed the written informed consent form
Key exclusion criteria (3 listed)
- Patient presenting a contra indication to rituximab (hypersensitivity, active infection, severe cardiac failure (NYHA class IV))
- Blood sampling impossibility
- Pregnant or breasting women
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 |
|---|---|---|
| Rituximab 375rituximab 375 mg/m2 IV weekly, during 4 weeks | Drug | 1 |
| rituximab 1000rituximab 1000 mg IV, two infusions on day 1 and day 15 | Drug | 2 |
Primary outcome
Comparison of the total AUC levels between 2 arms : patients treated by rituximab alone or patients treated by rituximab and plasma exchange
Time frame: Determination on the overall plasma concentration profile between the start of infusion and three months after the start of infusion
2 secondary outcomes
Determination of amount rituximab eliminated during a plasma exchange
Time frame: At each plasma exchange
Evaluation of the efficacy of the treatment by CD19+B Cell count
Time frame: 15 dyas, 1, 2, 3, 6 and 9 months after rituximab infusion
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 12 May 2017.
- Results publication: PubMed 23432476Puisset F, White-Koning M, Kamar N, Huart A, Haberer F, Blasco H, Le Guellec C, Lafont T, Grand A, Rostaing L, Chatelut E, Pourrat J. Population pharmacokinetics of rituximab with or without plasmapheresis in kidney patients with antibody-mediated disease. Br J Clin Pharmacol. 2013 Nov;76(5):734-40. doi: 10.1111/bcp.12098.
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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.
Jacques Pourrat, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rituximab 375 and rituximab 1000 in people with Renal Transplant and Autoimmune Diseases, run by University Hospital, Toulouse at 1 site in France.
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 3 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: finished, as of the sponsor's last update on 12 May 2017. 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 France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Comparison of the total AUC levels between 2 arms : patients treated by rituximab alone or patients treated by rituximab and plasma exchange (time frame: Determination on the overall plasma concentration profile between the start of infusion and three months after the start of infusion). 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 NCT00820469, 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 12 May 2017.