Safety and Dialysability of Dotarem® in Dialysed Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Dialysability of Dotarem® in Dialysed Patients - Phase 1 Clinical Study

Conditions
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End-stage Renal Failure

Intervention / Treatment
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* Drug: Dotarem® IV injection at 0.1 mmol/kg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dotarem®-injected patients<br>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<br>* Dotarem® was IV administered at a dose of 0.1 mmoL/kg (0.2 mL/kg).<br>* Other names: gadoteric acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Dotarem® dialysability assessed up to 4 days after Dotarem® administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Safety assessed from patients inclusion until the last follow-up visit 3 months after Dotarem® administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dotarem, Dialyses, Dialysed, Safety, Safety and dialysability of Dotarem in dialysed patients