Safety and Dialysability of Dotarem® in Dialysed Patients

End-stage Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449266
• Other study ID #: DGD-44-054
• Status: Completed
• Phase: Phase 1
• First received: October 3, 2011
• Last updated: June 9, 2015
• Start date: November 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2015
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• End-stage Renal Failure
• Kidney Failure, Chronic

Intervention

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).

Locations

Country	Name	City	State
Belgium	Clinical Pharmacology Unit Antwerp	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes