Safety and Dialysability of Dotarem® in Dialysed Patients

NCT01449266 | Completed Phase 1 Results DMC

• 1 other identifier: DGD-44-054
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End-stage Renal Failure

Keywords

Dotarem; Dialyses; Dialysed; Safety; Safety and dialysability of Dotarem in dialysed patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events.

  Safety assessed from patients inclusion until the last follow-up visit 3 months after Dotarem® administration

Study Arms (1)

Dotarem®-injected patients

OTHER

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

Interventions

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).

Also known as: gadoterate meglumine, gadoteric acid

Dotarem®-injected patients

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guerbet: lead

Study Sites (1)

Clinical Pharmacology Unit Antwerp

Antwerp, Belgium

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

gadoterate meglumine

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Pierre Desché, MD - VP Development, Medical and Regulatory Affairs
• Organization: Guerbet

pierre.desche@guerbet-group.com

+33 1 45 91 50 00

Study Officials

• Sofie Mesens, MD

  Clinical Pharmacology Unit Antwerp, Belgium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2011
• First Posted: October 10, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 8, 2015
• Results First Posted: June 8, 2015

Record last verified: 2015-06

Locations

BE (1)