Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00001298
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase Phase 1
Start date March 1992
Completion date January 2001

See also
  Status Clinical Trial Phase
Completed NCT03246984 - VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ N/A
Completed NCT03545113 - Graft-first Versus Fistula-first in Older Patients With End-stage Kidney Disease N/A
Recruiting NCT05100017 - Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure N/A
Recruiting NCT04559321 - Holmium Vs Trilogy Kidney Stones GUY's 1-2 Phase 3
Recruiting NCT05036850 - China Kidney Patient Trials Network
Completed NCT04037436 - Functional Exercise and Nutrition Education Program for Older Adults N/A
Active, not recruiting NCT01529658 - Renal Hypothermia During Partial Nephrectomy N/A
Completed NCT01679587 - Dose Escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BAY85-3934 in Subjects With Chronic Kidney Disease (CKD) Phase 1
Completed NCT01155141 - Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH Phase 4
Completed NCT00755690 - Study of Dietary Phosphate and Mineral Homeostasis in Early Chronic Kidney Disease N/A
Recruiting NCT05759754 - Effects of Traditional Chinese Medicine (GSJYF) in Children With Inherited Proteinuric Kidney Disease N/A
Completed NCT03213158 - Ixazomib for Desensitization Phase 2
Active, not recruiting NCT02237352 - Mechanisms of Diabetic Nephropathy in Ecuador
Recruiting NCT06067867 - Kidney and Pregnancy Registry
Recruiting NCT04110080 - Enhanced Recovery After Surgery in Kidney Transplant Donors N/A
Active, not recruiting NCT04876963 - HOLT-ED: Holter-monitoring in End-stage Renal Disease
Enrolling by invitation NCT05324878 - Honoring Individual Goals and Hopes: Implementing Advance Care Planning for Persons With Kidney Disease on Dialysis
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Active, not recruiting NCT04631965 - Healthcare Transition of Adolescents With Chronic Health Conditions
Completed NCT03394859 - Electronic Medical Records and Genomics (eMERGE) Phase III