Kidney DiseasesPhase 1/2NCT00298168
YSPSL for Prevention of Delayed Graft Function Part B
A Phase 1/2 study testing YSPSL in people with Kidney Diseases, run by Y's Therapeutics, Inc. at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- YSPSL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 15 sitesUnited States
- Study dates
- May 2006to Dec 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary cadaver renal transplants
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Rush University Medical Center
Chicago, Illinois, 60612
University of Cincinnati, Department of Internal Medicine
Cincinnati, Ohio, 45267
Baylor University Medical Center Transplantation Services
Dallas, Texas, 75246
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Henry Ford Hospital Transplant Institute
Detroit, Michigan, 48202
Shands Hospital at University of Florida
Gainesville, Florida, 32610
Westchester Medical Center, New York Medical College
Hawthorne, New York, 10532
The Methodist Hospital
Houston, Texas, 77030
University of Texas, Organ Transplantation
Houston, Texas, 77030
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Dumont-UCLA Transplant Center
Los Angeles, California, 90095
Methodist Healthcare University Hospital
Memphis, Tennessee, 38104
Tulane University Hospital & Clinic
New Orleans, Louisiana, 70112
California Pacific Medical Center Department of Transplantation
San Francisco, California, 94115
Lifelink Foundation
Tampa, Florida, 33606
About this study
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
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.
Read the 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.
- Conditions
- Kidney Diseases
- Being tested
- YSPSL, placebo
- Keywords
- Delayed Graft Function
- Medical subject headings
- Kidney Diseases, Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YSPSLDrug
Also called rPSGL-Ig, recombinant P-selectin glycoprotein ligand-Ig
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
placeboDrug
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
YSPSLDrug
Also called rPSGL-Ig, recombinant P-selectin glycoprotein ligand-Ig
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: YSPSL |
| 2 | Experimental | Not described Receives: Drug: YSPSL |
| 3 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
delayed graft function post transplant
Measured: 6 months
Secondary outcomes (1)
renal function parameters through 6 months post transplant
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2006 (estimated)
- Study startMay 2006
- Primary completionSep 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Y's Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stefan Hemmerich, PhD, Study director, Y's Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298168
- Sponsor's protocol ID
- YSPSL-0001-PF Part B
- Status last verified
- Jan 2008
- First submitted
- 27 Feb 2006
- Last updated
- 29 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
- Expanded access
- Available
Publications
Cheadle C, Watkins T, Ehrlich E, Barnes K, Gaber AO, Hemmerich S, Rabb H. Effects of anti-adhesive therapy on kidney biomarkers of ischemia reperfusion injury in human deceased donor kidney allografts. Clin Transplant. 2011 Sep-Oct;25(5):766-75. doi: 10.1111/j.1399-0012.2010.01365.x. Epub 2010 Nov 28.
PubMed 21114535Gaber AO, Mulgaonkar S, Kahan BD, Woodle ES, Alloway R, Bajjoka I, Jensik S, Klintmalm GB, Patton PR, Wiseman A, Lipshutz G, Kupiec-Weglinski J, Gaber LW, Katz E, Irish W, Squiers EC, Hemmerich S. YSPSL (rPSGL-Ig) for improvement of early renal allograft function: a double-blind, placebo-controlled, multi-center Phase IIa study. Clin Transplant. 2011 Jul-Aug;25(4):523-33. doi: 10.1111/j.1399-0012.2010.01295.x. Epub 2010 Jun 22.
PubMed 20573162
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00298168
- Acronym / sponsor ID
- YSPSL-0001-PF Part B
- Conditions
- Kidney Diseases
- Keywords
- Delayed Graft Function
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Y's Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 1 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: YSPSL |
| 2 | Experimental | Drug: YSPSL |
| 3 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing primary cadaver renal transplants
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YSPSLAlso: rPSGL-Ig, recombinant P-selectin glycoprotein ligand-IgYSPSL 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 | Drug | 1 |
| placebo0.9% 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 | Drug | 3 |
| YSPSLAlso: rPSGL-Ig, recombinant P-selectin glycoprotein ligand-IgYSPSL 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 | Drug | 2 |
Primary outcome
delayed graft function post transplant
Time frame: 6 months
1 secondary outcome
renal function parameters through 6 months post transplant
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2008.
- Derived from this study: PubMed 21114535Cheadle C, Watkins T, Ehrlich E, Barnes K, Gaber AO, Hemmerich S, Rabb H. Effects of anti-adhesive therapy on kidney biomarkers of ischemia reperfusion injury in human deceased donor kidney allografts. Clin Transplant. 2011 Sep-Oct;25(5):766-75. doi: 10.1111/j.1399-0012.2010.01365.x. Epub 2010 Nov 28.
- Derived from this study: PubMed 20573162Gaber AO, Mulgaonkar S, Kahan BD, Woodle ES, Alloway R, Bajjoka I, Jensik S, Klintmalm GB, Patton PR, Wiseman A, Lipshutz G, Kupiec-Weglinski J, Gaber LW, Katz E, Irish W, Squiers EC, Hemmerich S. YSPSL (rPSGL-Ig) for improvement of early renal allograft function: a double-blind, placebo-controlled, multi-center Phase IIa study. Clin Transplant. 2011 Jul-Aug;25(4):523-33. doi: 10.1111/j.1399-0012.2010.01295.x. Epub 2010 Jun 22.
Related trials for Kidney Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Hemmerich, PhD study director
Y's Therapeutics, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing YSPSL in people with Kidney Diseases, run by Y's Therapeutics, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delayed graft function post transplant (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00298168, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2008.