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Completed

NCT Number: NCT00219791

Study of Glucarpidase (CPG2) for the Management of Patients With Delayed Methotrexate Clearance

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.

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Key information

Conditions

Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charite - Universitätsmedizin Berlin

Berlin, 12200, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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).

Exclusion criteria

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

Treatment and study plan

glucarpidase (50 Units/kg)

Drug

Primary outcomes

  1. Reduction in serum MTX concentration

Secondary outcomes

  1. serum blood-urea-nitrogen

  2. serum creatinine

  3. creatinine clearance

  4. haematology (complete blood count and differential)

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

  6. urinalysis (dip-stick)

  7. MTX-related toxicity

  8. Adverse events

  9. Mortality

Sponsors and collaborators

Lead sponsor

BTG International Inc.

Other

Registry information

Official study title

Study of Recombinant Carboxypeptidase G2 (CPG2) for the Management of Patients With Delayed Methotrexate (MTX) Clearance or Intrathecal MTX Overdosage

Important dates

Study start
2000
Study completion
2003
First posted
Sep 22, 2005
Registry last updated
Sep 11, 2014

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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