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Completed

NCT Number: NCT01449266

Safety and Dialysability of Dotarem® in Dialysed Patients

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.

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Key information

Conditions

End-stage Renal Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Unit Antwerp

Antwerp, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dotarem® IV injection at 0.1 mmol/kg

Drug

Dotarem® was IV administered at a dose of 0.1 mmoL/kg (0.2 mL/kg).

Other names: gadoterate meglumine, gadoteric acid

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Guerbet

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 10, 2011
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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