NCT00219791

Brief Summary

To evaluate the safety and efficacy of glucarpidase in patients with impaired methotrexate (MTX) clearance owing to MTX-induced renal failure following high-dose MTX therapy, or with intrathecal MTX overdose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2000

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

First QC Date

September 15, 2005

Last Update Submit

September 10, 2014

Conditions

Neoplasms

Keywords

methotrexatedelayed eliminationrenal insufficiencyCPG2Voraxaze

Outcome Measures

Primary Outcomes (1)

  • Reduction in serum MTX concentration

Secondary Outcomes (9)

  • serum blood-urea-nitrogen

  • serum creatinine

  • creatinine clearance

  • haematology (complete blood count and differential)

  • biochemistry (electrolytes, SGOT, SGPT, alkaline phosphatase, bilirubin, total protein)

  • +4 more secondary outcomes

Interventions

glucarpidase (50 Units/kg)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent by patient or legally valid representative
  • Patients receiving high-dose MTX (\>1 g/m2 body surface area (BSA) given as an infusion over 24 hours) for the treatment of ALL, NHL or a solid tumour (e.g. osteosarcoma)
  • Age ≥ 18 years
  • Serum MTX \>5 µmol/L 42 hours or later after the start of MTX infusion, or serum MTX \>1 μmol/L 42 hours or later after the start of MTX infusion together with renal insufficiency, or serum MTX \>0.4 µmol/L 48 hours or later after the start of MTX infusion together with renal insufficiency. Renal insufficiency was defined as serum creatinine \>1.5 × the upper limit of normal (ULN) and/or oliguria (urine output \< 500 mL/24 hours despite adequate hydration, diuretics and alkalinisation).

You may not qualify if:

  • Pregnant or lactating females
  • Unwillingness of patient or relative/legal representative to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite - Universitätsmedizin Berlin

Berlin, 12200, Germany

Location

MeSH Terms

Conditions

NeoplasmsRenal Insufficiency

Interventions

glucarpidase

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Thiel Eckhard, Prof. Dr.med.

    Charite - Universitätsmedizin Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

January 1, 2000

Study Completion

June 1, 2003

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations

DE(1)