A Phase 1 interventional study of Dotarem® IV injection at 0.1 mmol/kg in End-stage Renal Failure, sponsored by Guerbet. Completed at 1 site in Belgium. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2015-07-08.
Sponsored by Guerbet · Phase 1 and Interventional
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.
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.
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This study's enrollment of 10 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
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Male or female, aged ≥18 years
Exclusion Criteria:
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.
Drug: Dotarem® IV injection at 0.1 mmol/kg
Dotarem® was IV administered at a dose of 0.1 mmoL/kg (0.2 mL/kg).
Also known as: gadoterate meglumine, gadoteric acid
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)
Time frame: Dotarem® dialysability assessed up to 4 days after Dotarem® administration
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.
Time frame: Safety assessed from patients inclusion until the last follow-up visit 3 months after Dotarem® administration
| Milestone | Dotarem® Injected Patients |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
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)
| percent change in Gd concentration | Dotarem® Injected Patients |
|---|---|
| Percent change at 0.5h after first hemodialysis | -88.2 (-93.5 to -84.7) |
| Percent change at 1.5h after first hemodialysis | -93.4 (-95.7 to -90.3) |
| Percent change at 4h after first hemodialysis | -97.1 (-99.1 to -90.5) |
| Percent change at 4h after second hemodialysis n=7 | -94.8 (-97.7 to -84.8) |
| Percent change at 4h after third hemodialysis n=2 | -89.9 (-94.9 to -85.0) |
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.
| participants | Dotarem® Injected Patients |
|---|---|
| Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events. | 8 |
Evaluation of the decrease in seric concentration of gadolinium, 4h after the second hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem®. The percent change of gadolinium concentration was estimated from the concentration of gadolinium after Dotarem® injection. Only subjects with gadolinium concentration above the lower limit of quantification (LLQ) were kept for analysis.
| Percent change in Gd concentration | Dotarem® Injected Patients |
|---|---|
| Percent Change in Gadolinium Serum Concentration 4h After Second Hemodialysis Session, Estimated From Subjects With Concentration Data Above the Limit of Detection | -99.5 (-99.8 to -98.6) |
The evaluation of the decrease in seric concentration of gadolinium, 4h after the third hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem®. The percent change of gadolinium concentration was estimated from the concentration of gadolinium after Dotarem® injection. Only subjects with gadolinium concentration above the lower limit of detection were kept for analysis.
| percent change in Gd concentration | Dotarem® Injected Patients |
|---|---|
| Percent Change in Gadolinium Serum Concentration 4h After Third Hemodialysis Session, Estimated From Subjects With Concentration Data Above the Limit of Detection | -99.7 (-99.8 to -99.7) |
Collected over Safety assessment was performed at the day 1, day 2, and day 4 after Dotarem® injection. Two safety follow-up visits were performed at 3 weeks (+/- 2 days) and at 3 months (+/- 4 days) after Dotarem® injection.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dotarem® Injected Patients | — | 4/10 (40%) | 8/10 (80%) |
| Event | Dotarem® Injected Patients |
|---|---|
| moderate sepsisInfections and infestations | 2/10 |
| severe respiratory failureRespiratory, thoracic and mediastinal disorders | 1/10 |
| severe peripheral ischemiaVascular disorders | 1/10 |
| moderate thrombocytopeniaBlood and lymphatic system disorders | 1/10 |
| severe urosepsisInfections and infestations | 1/10 |
| Dialysis device insertionSurgical and medical procedures | 1/10 |
| NephrectomySurgical and medical procedures | 1/10 |
| Event | Dotarem® Injected Patients |
|---|---|
| HypotensionVascular disorders | 5/10 |
| HeadacheNervous system disorders | 3/10 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 3/10 |
| AnemiaBlood and lymphatic system disorders | 1/10 |
| Abdominal painGastrointestinal disorders | 1/10 |
| influenza-like illnessGeneral disorders | 1/10 |
| thirstGeneral disorders | 1/10 |
| Procedural painInjury, poisoning and procedural complications | 1/10 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/10 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 1/10 |
No statistical calculation of sample size was done. According to the literature, a sample of 10 patients was judged sufficient to evaluate the dialysability of Dotarem®.
| Age, Categorical(Participants) | Dotarem®-Injected Patients |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 5 |
| Age, Continuous(years) | Dotarem®-Injected Patients |
|---|---|
| Median | 64.0 (31 to 79) |
| Sex: Female, Male(Participants) | Dotarem®-Injected Patients |
|---|---|
| Female | 5 |
| Male | 5 |
| Region of Enrollment(participants) | Dotarem®-Injected Patients |
|---|---|
| Belgium | 10 |
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