YSPSL for Prevention of Delayed Graft Function Part B
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| ClinicalTrials.gov Identifier: NCT00298168 |
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Recruitment Status :
Completed
First Posted : March 1, 2006
Last Update Posted : January 29, 2008
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Sponsor:
Y's Therapeutics, Inc.
Information provided by:
Y's Therapeutics, Inc.
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Kidney Diseases | Drug: YSPSL Drug: placebo | Phase 1 Phase 2 |
Expanded Access : Y's Therapeutics, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | May 2006 |
| Actual Primary Completion Date : | September 2007 |
| Actual Study Completion Date : | December 2007 |
| Arm | Intervention/treatment |
|---|---|
| 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:
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| 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:
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| 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 |
Primary Outcome Measures :
- delayed graft function post transplant [ Time Frame: 6 months ]
Secondary Outcome Measures :
- renal function parameters through 6 months post transplant [ Time Frame: 6 months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| University of Texas, Organ Transplantation | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Y's Therapeutics, Inc.
Investigators
| Study Director: | Stefan Hemmerich, PhD | Y's Therapeutics, Inc. |
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 |
| Other Study ID Numbers: |
YSPSL-0001-PF Part B |
| First Posted: | March 1, 2006 Key Record Dates |
| Last Update Posted: | January 29, 2008 |
| Last Verified: | January 2008 |
Keywords provided by Y's Therapeutics, Inc.:
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Delayed Graft Function |
Additional relevant MeSH terms:
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Kidney Diseases Delayed Graft Function Urologic Diseases Pathologic Processes polysaccharide-K Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
Antibiotics, Antineoplastic Antineoplastic Agents Antiviral Agents Anti-Infective Agents Interferon Inducers Radiation-Protective Agents Protective Agents |