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NCT00001298 · ClinicalTrials.gov registry record · Phase 1

A Trial of Carboxypeptidase-G2 (CPDG2) and Thymidine for the Management of Patients With Methotrexate Toxicity and Renal Dysfunction

A Phase 1 study of Kidney Diseases, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
10
Enrollment target
1
Study location

NCT00001298: Completed Phase 1 study of Kidney Diseases, sponsored by National Cancer Institute (NCI).

NCT00001298 is a Phase 1 study of Kidney Diseases that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants, below the 1,785-participant average among 38 other Kidney Diseases trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00001298, a Phase 1 study of Kidney Diseases, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target
1
Study location

Study Summary

High dose methotrexate with leucovorin rescue has demonstrated activity in numerous malignancies. Although high dose methotrexate is generally well tolerated, unpredictable life-threatening toxicity can occur. For patients who have markedly delayed clearance of methotrexate secondary to renal dysfunction, therapeutic options are few and are of limited efficacy. Carboxypeptidase-G2 inactivates methotrexate by hydrolyzing its C-terminal glutamate residue. Carboxypeptidase-G2 could be used to rescue patients with renal dysfunction and delayed methotrexate excretion, as it provides an alternative to renal clearance as a route of elimination.

Conditions Studied

Interventions

  • DRUG carboxypeptidase-G2

Study Locations (1)

Maryland

  • National Cancer Institute (NCI) - Bethesda

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 1992-03
Est. Completion 2001-01
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00001298

The ClinicalTrials.gov registry entry for NCT00001298 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,785-participant average among 38 other Kidney Diseases trials with a reported enrollment target (99% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Kidney Diseases appearing as the primary indexed condition, and to 1 intervention - of which carboxypeptidase-G2 is the first listed.

NCT00001298 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00001298 about?

NCT00001298 is a clinical study titled "A Trial of Carboxypeptidase-G2 (CPDG2) and Thymidine for the Management of Patients With Methotrexate Toxicity and Renal Dysfunction". High dose methotrexate with leucovorin rescue has demonstrated activity in numerous malignancies. Although high dose methotrexate is generally well tolerated, unpredictable life-threatening toxicity can occur. For patients who have markedly delayed clearance of methotrexate secondary to renal dysfun...

What is the current status of trial NCT00001298?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 1992-03. Estimated completion is 2001-01.

What conditions does trial NCT00001298 study?

This clinical trial studies the following conditions: Kidney Diseases.

What interventions are being tested in trial NCT00001298?

The interventions under investigation include: carboxypeptidase-G2 (DRUG).

Who is sponsoring clinical trial NCT00001298?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001298 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.