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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 1992-03 |
| Est. Completion | 2001-01 |
| Phase | Phase 1 |
What the finished NCT00001298 record still lists
NCT00001298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,785-participant average among 38 other Kidney Diseases trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Kidney Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00001298's enrollment target sits among peer trials
10 39th of 38 the lowest of 38 other Kidney Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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