YSPSL for Prevention of Delayed Graft Function Part B
This study has been completed.
Sponsor:
Y's Therapeutics, Inc.
Information provided by:
Y's Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00298168
First received: February 27, 2006
Last updated: January 24, 2008
Last verified: January 2008
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Purpose
Selectins have been implicated in the pathogenesis of ischemia/reperfusion (I/R)-induced kidney injury and resultant delayed graft function (DGF). PSGL-1 is a ligand for P-, E-, and L-selectin. It has been reported that YSPSL (rPSGL-Ig) blocks P-selectin and, to a lesser degree, E- and L-selectin. Both sPSGL-1 and YSPSL (rPSGL-Ig) have been shown in animal models to reduce both cytokines and tissue damage associated with ischemia reperfusion and to improve renal function post-transplant. Therefore, the current phase I/II clinical study is designed to assess the safety and efficacy of YSPSL (rPSGL-Ig) in preventing DGF in patients undergoing cadaveric kidney transplants and to determine a dose for future pivotal studies.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Diseases |
Drug: YSPSL Drug: placebo |
Phase 1 Phase 2 |
Y's Therapeutics, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, Dose-Escalation Study of the Safety, PK, and Efficacy of YSPSL for Prevention of Delayed Graft Function in Patients Undergoing Cadaveric Kidney Transplantation |
Resource links provided by NLM:
Further study details as provided by Y's Therapeutics, Inc.:
Primary Outcome Measures:
- delayed graft function post transplant [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- renal function parameters through 6 months post transplant [ Time Frame: 6 months ]
| Enrollment: | 60 |
| Study Start Date: | May 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: YSPSL
YSPSL administered intravenously (IV) as a single bolus infusion of 1 mg/kg with 200 mL Lactated Ringer's for Injection USP total volume administered as an ex vivo flush intra-arterially to donor organ prior to implantation
Other Names:
|
| Experimental: 2 |
Drug: YSPSL
YSPSL administered intravenously (IV) as a single bolus infusion of 1 mg/kg with 10 mg YSPSL in 200 mL Lactated Ringer's for Injection USP total volume administered as an ex vivo flush intra-arterially to donor organ prior to implantation
Other Names:
|
| Placebo Comparator: 3 |
Drug: placebo
0.9% normal saline administered IV as a single bolus infusion with 200 mL Lactated Ringer's for Injection USP total volume administered as an ex vivo flush intra-arterially to donor organ prior to implantation
|
Detailed Description:
This will be a multicenter, single-dose, dose-escalation study. The study will be in 2 parts: the first, Part A, will be an open label evaluation of single doses of four dose cohorts; the second, Part B will be a randomized, double-blind, placebo-controlled, single-dose study of two dose cohorts. Patients who are undergoing cadaveric kidney transplantation and are at risk for development of DGF, based upon known risk factors, will be eligible to participate in the study. A maximum of 24 patients will be enrolled in Part A. 60 patients will be enrolled in Part B.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients undergoing primary cadaver renal transplants
Exclusion Criteria:
- Patient has a planned transplant of a donor kidney from a non-heart beating donor
- Patient has a planned transplant of kidneys that are implanted en bloc (dual kidney transplant) or from donors < 6 years of age
- Patient has a planned transplant of a kidney from a donor who has received investigational therapies designed to reduce the impact of ischemia/reperfusion (I/R) injury, DGF, or other donor-related immune events
- Patient is planned to receive a living donor kidney; or patient is planned to receive an ABO-incompatible donor kidney
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298168
Locations
| United States, California | |
| Dumont-UCLA Transplant Center | |
| Los Angeles, California, United States, 90095 | |
| California Pacific Medical Center Department of Transplantation | |
| San Francisco, California, United States, 94115 | |
| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Florida | |
| Shands Hospital at University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| Lifelink Foundation | |
| Tampa, Florida, United States, 33606 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Louisiana | |
| Tulane University Hospital & Clinic | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Michigan | |
| Henry Ford Hospital Transplant Institute | |
| Detroit, Michigan, United States, 48202 | |
| United States, New Jersey | |
| Saint Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07039 | |
| United States, New York | |
| Westchester Medical Center, New York Medical College | |
| Hawthorne, New York, United States, 10532 | |
| United States, Ohio | |
| University of Cincinnati, Department of Internal Medicine | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Tennessee | |
| Methodist Healthcare University Hospital | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Baylor University Medical Center Transplantation Services | |
| Dallas, Texas, United States, 75246 | |
| University of Texas, Organ Transplantation | |
| Houston, Texas, United States, 77030 | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Y's Therapeutics, Inc.
Investigators
| Study Director: | Stefan Hemmerich, PhD | Y's Therapeutics, Inc. |
More Information
No publications provided by Y's Therapeutics, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Stefan Hemmerich, PhD, RAC, Y's Therapeutics Inc. |
| ClinicalTrials.gov Identifier: | NCT00298168 History of Changes |
| Other Study ID Numbers: | YSPSL-0001-PF Part B |
| Study First Received: | February 27, 2006 |
| Last Updated: | January 24, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Y's Therapeutics, Inc.:
|
Delayed Graft Function |
Additional relevant MeSH terms:
|
Kidney Diseases Delayed Graft Function Urologic Diseases Pathologic Processes Krestin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Antiviral Agents Anti-Infective Agents Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Interferon Inducers Radiation-Protective Agents Protective Agents |
ClinicalTrials.gov processed this record on June 18, 2013