End-stage Renal FailurePhase 1NCT01449266
Safety and Dialysability of Dotarem® in Dialysed Patients
A Phase 1 study testing Dotarem® IV injection at 0.1 mmol/kg in people with End-stage Renal Failure, run by Guerbet at 1 site in Belgium.
Trial summary
To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients with chronic renal failure who require hemodialysis treatment. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- End-stage Renal Failure
- What is being tested?
- Dotarem® IV injection at 0.1 mmol/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2011to Jun 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged ≥18 years
- Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)
- Female Subjects with effective contraception (contraceptive pill or Intra-Uterine Device), or surgically sterilized or post-menopausal (minimum 12 months amenorrhea)
- Subjects having provided their written informed consent to participate in the trial
Who cannot join
- Known allergy to gadolinium chelates
- Pregnant, breast feeding, or planning to become pregnant during the trial
- Having received or scheduled to be injected with any contrast agent within 7 days before or after the Dotarem® injection
- Schedule to receive erythropoietin (EPO) or iron therapy during 1 week after the Dotarem® injection
- Evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- Evidence of hepatitis C and/or positive hepatitis C antibody and/or positive hepatitis B surface antigen
- History of hypersensitivity to drugs with a similar chemical structure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Dialysability of Dotarem® in Dialysed Patients - Phase 1 Clinical Study
To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients with chronic renal failure who require hemodialysis treatment.
Read the detailed description
Ten adult patients suffering from end stage renal failure and requiring hemodialysis treatment for 3 times were enrolled. Patients received a single dose of Dotarem® at 0.1 mmol/kg before being submitted to hemodialysis to assess the dialysability of Dotarem® . After injection of Dotarem®, 3 sessions of hemodialysis were performed as follows:
The first hemodialysis session started between 1 to 2 h after the injection; The second hemodialysis session occurred 2 days (i.e., 48 ± 2 h) after the Dotarem® injection; The third hemodialysis session occurred 4 days (i.e., 96 ± 4 h) after the Dotarem® injection.
The decrease in serum Dotarem® concentration was assessed after each hemodialysis session. Safety assessments included adverse events (AEs), vital signs, injection-site tolerance, and laboratory assessments.Two safety follow-up visits were performed: one 3 weeks (± 2 days) and one 3 months (± 4 days) after the Dotarem® injection.
- Conditions
- End-stage Renal Failure
- Being tested
- Dotarem® IV injection at 0.1 mmol/kg
- Keywords
- Dotarem, Dialyses, Dialysed, Safety, Safety and dialysability of Dotarem in dialysed patients
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dotarem® IV injection at 0.1 mmol/kgDrug
Also called gadoterate meglumine, gadoteric acid
Dotarem® was IV administered at a dose of 0.1 mmoL/kg (0.2 mL/kg).
| Study group | Role | What they receive |
|---|---|---|
| Dotarem®-injected patients | Other | Male or female subjects, aged ≥18 years,suffering from end-stage renal failure and requiring hemodialysis treatment 3 times per week, were submitted to a single Dotarem® IV injection at 0.1 mmol/kg before being submitted to 3 hemodialysis sessions to assess the decrease of Dotarem® concentration in the blood. Receives: Drug: Dotarem® IV injection at 0.1 mmol/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialysability of Dotarem® in Dialysed Patients
To evaluate the decrease in seric concentration of gadolinium, after each hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem® . The percent change of gadolinium concentration is calculated by estimating the amount of serum gadolinium before and after each hemodialysis session. Calculations are performed only for subjects with concentration above the lower limit of quantification (LLQ)
Measured: Dotarem® dialysability assessed up to 4 days after Dotarem® administration
Secondary outcomes (1)
Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events.
To evaluate the biological and clinical safety of Dotarem® by assessing vital signs, biological parameters, injection-site tolerance, through a 4-day post injection follow-up, adverse events through a 3-week post injection period and serious adverse events through a 3-month post injection period.
Measured: Safety assessed from patients inclusion until the last follow-up visit 3 months after Dotarem® administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End-stage Renal FailureStudies 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sofie Mesens, MD, Principal investigator, Clinical Pharmacology Unit Antwerp, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449266
- Sponsor's protocol ID
- DGD-44-054
- Status last verified
- Jun 2015
- First submitted
- 3 Oct 2011
- Last updated
- 8 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Dialysability of Dotarem® in Dialysed Patients - Phase 1 Clinical Study
- ClinicalTrials.gov ID
- NCT01449266
- Acronym / sponsor ID
- DGD-44-054
- Conditions
- End-stage Renal Failure
- Keywords
- Dotarem, Dialyses, Dialysed, Safety, Safety and dialysability of Dotarem in dialysed patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Oct 2011 (estimated)
- Results
- Posted 8 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients with chronic renal failure who require hemodialysis treatment.
Detailed description
Ten adult patients suffering from end stage renal failure and requiring hemodialysis treatment for 3 times were enrolled. Patients received a single dose of Dotarem® at 0.1 mmol/kg before being submitted to hemodialysis to assess the dialysability of Dotarem® . After injection of Dotarem®, 3 sessions of hemodialysis were performed as follows:
The first hemodialysis session started between 1 to 2 h after the injection; The second hemodialysis session occurred 2 days (i.e., 48 ± 2 h) after the Dotarem® injection; The third hemodialysis session occurred 4 days (i.e., 96 ± 4 h) after the Dotarem® injection.
The decrease in serum Dotarem® concentration was assessed after each hemodialysis session. Safety assessments included adverse events (AEs), vital signs, injection-site tolerance, and laboratory assessments.Two safety follow-up visits were performed: one 3 weeks (± 2 days) and one 3 months (± 4 days) after the Dotarem® injection.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dotarem®-injected patients | Other | Drug: Dotarem® IV injection at 0.1 mmol/kgMale or female subjects, aged ≥18 years,suffering from end-stage renal failure and requiring hemodialysis treatment 3 times per week, were submitted to a single Dotarem® IV injection at 0.1 mmol/kg before being submitted to 3 hemodialysis sessions to assess the decrease of Dotarem® concentration in the blood. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged ≥18 years
- Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)
- Female Subjects with effective contraception (contraceptive pill or Intra-Uterine Device), or surgically sterilized or post-menopausal (minimum 12 months amenorrhea)
- Subjects having provided their written informed consent to participate in the trial
Key exclusion criteria (7 listed)
- Known allergy to gadolinium chelates
- Pregnant, breast feeding, or planning to become pregnant during the trial
- Having received or scheduled to be injected with any contrast agent within 7 days before or after the Dotarem® injection
- Schedule to receive erythropoietin (EPO) or iron therapy during 1 week after the Dotarem® injection
- Evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
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 |
|---|---|---|
| Dotarem® IV injection at 0.1 mmol/kgAlso: gadoterate meglumine, gadoteric acidDotarem® was IV administered at a dose of 0.1 mmoL/kg (0.2 mL/kg). | Drug | Dotarem®-injected patients |
Primary outcome
Dialysability of Dotarem® in Dialysed Patients
Time frame: Dotarem® dialysability assessed up to 4 days after Dotarem® administration
To evaluate the decrease in seric concentration of gadolinium, after each hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem® . The percent change of gadolinium concentration is calculated by estimating the amount of serum gadolinium before and after each hemodialysis session. Calculations are performed only for subjects with concentration above the lower limit of quantification (LLQ)
1 secondary outcome
Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events.
Time frame: Safety assessed from patients inclusion until the last follow-up visit 3 months after Dotarem® administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sofie Mesens, MD principal investigator
Clinical Pharmacology Unit Antwerp, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dotarem® IV injection at 0.1 mmol/kg in people with End-stage Renal Failure, run by Guerbet at 1 site in Belgium.
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 4 inclusion and 7 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 8 Jul 2015. 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 Belgium. 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 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?
Yes. Results are posted in the registry (first posted 8 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dialysability of Dotarem® in Dialysed Patients (time frame: Dotarem® dialysability assessed up to 4 days after Dotarem® administration). 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 8 Jul 2015.