Safety and Dialysability of Dotarem® in Dialysed Patients

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.

Study Overview

• Status: Completed
• Conditions: End-stage Renal Failure
• Intervention / Treatment: Drug: Dotarem® IV injection at 0.1 mmol/kg

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • Clinical Pharmacology Unit Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dotarem®-injected patients; 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).; Other Names: gadoteric acid; gadoterate meglumine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guerbet
• Investigators: Principal Investigator: Sofie Mesens, MD, Clinical Pharmacology Unit Antwerp, Belgium

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: October 3, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (Estimate): October 10, 2011

Study Record Updates

• Last Update Posted (Estimate): July 8, 2015
• Last Update Submitted That Met QC Criteria: June 9, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Safety; Dotarem; Dialyses; Dialysed; Safety and dialysability of Dotarem in dialysed patients
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
• Other Study ID Numbers: DGD-44-054