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Delayed Graft FunctionPhase 1/2NCT00802347

I5NP for Prophylaxis of Delayed Graft Function in Kidney Transplantation

A Phase 1/2 study testing I5NP and Saline in people with Delayed Graft Function and Other Complication of Kidney Transplant, run by Quark Pharmaceuticals at 50 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether a single administration of QPI-1002 (also known as I5NP) can prevent DGF in patients undergoing deceased donor kidney transplantation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
I5NP and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
374 participants
Where
50 sitesin 5 countries
Study dates
Dec 2008to May 2014
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

  • Patient is at least 18 years of age.
  • Patient has given informed consent.
  • Patient is willing to practice birth control. Female patients must be: (1) post-menopausal (2) surgically sterile, or (3) using an effective means of contraception (per the site-specific guidelines or using 2 methods of birth control concurrently, whichever is more stringent) which will be continued until the Study Day 90 visit with a negative pregnancy test within 48 hours prior to administration of study drug. Male patients with female partners of child bearing potential must agree to use an effective means of contraception (per the site-specific guidelines or using 2 methods of birth control concurrently, whichever is more stringent) which will be continued until the Study Day 90 visit. Note: For the purpose of this study, post menopausal is defined as the absence of menses consistent with ESRD. A woman is considered to be surgically sterilized if she has had a bilateral tubal ligation for at least 6 months prior to administration of study drug, bilateral oophorectomy, or complete hysterectomy.
  • Women of childbearing potential test negative for pregnancy (either urine or serum) within 48 hours prior to transplant.
  • Patient is up-to-date on cancer screening according to site-specific guidelines and the past medical history is negative for biopsy-confirmed malignancy within 5 years of randomization, with the exception of adequately treated basal cell or squamous cell carcinoma in situ.
  • Patient is scheduled to receive kidney transplant from a deceased donor meeting the following criteria:
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  • Part A:
  • receipt of an extended criteria donor (ECD) kidney, or
  • receipt of a kidney donated after cardiac death (DCD), or
  • receipt of a standard criteria donor (SCD) with cold ischemia time (CIT) ≥ 24 hours.
  • Part B:
  • receipt of an ECD kidney that has been preserved by cold storage (ECD/CS) for the entire period of cold ischemia time (CIT), regardless of duration
  • receipt of an ECD kidney that has been preserved by machine perfusion (ECD/MP) for any interval of time during the period of cold ischemia, where total CIT has been at least 26 hours
  • receipt of an SCD kidney that has been preserved by cold storage (SCD/CS) where total CIT has been at least 26 hours
  • receipt of an SCD kidney that has been preserved by machine perfusion (SCD/MP) for any interval of time during the period of cold ischemia, where total CIT has been at least 26 hours.
  • Patient is dialysis dependent at the time of transplant as documented by: a) the requirement for at least 2 dialysis sessions/week during the 56 days prior to transplant, or b) the planned removal of any remaining native kidney at the time of transplant, or c) the opinion of the investigator that the patient has no remaining native renal function (Part A only), or d) the investigator has provided documentation to the Medical Monitor that the patient has no remaining native renal function (e.g., documentation that the patient is anuric, with urine output <50 mL/day) (Part B only).

Who cannot join

  • Patient has participated in an investigational drug study in the last 30 days.
  • Patient has known allergy or has participated in prior study with siRNA.
  • Patient is HCV-positive
  • Patient is HIV-positive
  • Patient is scheduled to undergo multiorgan transplantation.
  • Patient has a planned transplant of kidneys that are implanted en bloc (dual kidney transplant).
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  • Patient has planned transplant of kidneys from donors < 6 years of age.
  • Patient has planned transplant of dual kidneys (from the same donor) transplanted not en bloc (as in the case of dual ECD donor kidneys).
  • Patient is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy (under another IND) for ischemic/reperfusion injury immediately prior to organ recovery.
  • Patient is scheduled to receive a living donor kidney.
  • Patient is scheduled to receive an ABO-incompatible donor kidney.
  • Patient is scheduled to receive an organ from a donor that meets both DCD and ECD criteria.
  • Patient is scheduled to receive an organ from a donor that meets DCD criteria (exclusion applicable to Part B only).
  • Patient has history or presence of a medical condition or disease that in the investigator's assessment would place the patient at an unacceptable risk for study participation.

Trial locations and contacts

50 sites in 5 countries.

50 sites in 5 countries

United States33 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado Health Science Center

    Aurora, Colorado, 80045

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Rush University

    Chicago, Illinois, 60612

  • University of Illinois Chicago

    Chicago, Illinois, 60612

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Duke University

    Durham, North Carolina, 27710

  • Baylor All Saints Medical Center

    Fort Worth, Texas, 76104

  • University of Florida

    Gainesville, Florida, 32610

  • The Methodist Hospital

    Houston, Texas, 77030

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • University of Southern California

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Transplant Research Institute (TRI; formerly NIT)

    Los Angeles, California, 90057

  • UCLA Medical Center

    Los Angeles, California, 90095

  • University of Miami

    Miami, Florida, 33136

  • Columbia University

    New York, New York, 10032

  • Cornell University

    New York, New York, 10065

  • Virginia Commonwealth University (MCV)

    Richmond, Virginia, 23298

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • UC Davis Medical Center

    Sacramento, California, 95817

  • California Pacific Medical Center

    San Francisco, California, 94115

  • UCSF Medical Center

    San Francisco, California, 94143

  • Lifelink Healthcare Institute

    Tampa, Florida, 33606

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Wake Forest University Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany7 sites

  • Charité - Universitätsmedizin Berlin

    Berlin

  • Charité, Campus Virchow-Klinikum

    Berlin

  • Kliniken der Stadt Köln gGmbH

    Cologne

  • Universitätklinikum Hamburg-Eppendorf

    Hamburg

  • Universitätsklinikum Heidelberg

    Heidelberg

  • Universitätsmedizin Mannheim

    Mannheim

  • Universitätsklinikum Tübingen

    Tübingen

Other trials in Germany

Canada4 sites

  • QE II Capital District Health Authority, Halifax

    Halifax, Nova Scotia

  • MUHC Royal Victoria Hospital

    Montreal, Quebec

  • St. Paul's Hospital, Univeristy of BC

    Vancouver, British Columbia

  • UBC - Division of Nephrology

    Vancouver, British Columbia

Other trials in Canada

France3 sites

  • Hôpital Pasteur

    Nice

  • Hôpital Necker

    Paris

  • CHU Rangueil

    Toulouse

Other trials in France

Spain3 sites

  • Hospital de bellvitge

    Barcelona

  • Hospital del mar

    Barcelona

  • Hospital Vall Hebron

    Barcelona

Other trials in Spain

About this study

Official title: Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, Dose-Escalation Study of the Safety, PK, and Clinical Activity of I5NP for Prophylaxis of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation

The purpose of this study is to determine whether a single administration of QPI-1002 (also known as I5NP) can prevent DGF in patients undergoing deceased donor kidney transplantation. In this Phase I /II study, patients who are undergoing renal transplantation with organs from DCD donors, ECD donors or SCD donors with ≥ 24 hours of cold ischemia time who meet study entry criteria will be studied to evaluate the safety and pharmacokinetic profile of I5NP (Part A) and clinical activity of I5NP administration (Part B). Data from this study will be used to identify doses of I5NP to be used in follow-on efficacy studies.

Part A will be a randomized, dose escalation study to determine the highest or maximum tolerated dose (MTD). Part A will enroll 40 patients at approximately 20 sites; patients will be randomized to receive either I5NP or placebo in a ratio of 8:2 in each cohort (cohorts 1-4).

Part B will utilize the dose identified in Part A to further evaluate, in a double-blind manner, the safety, and clinical activity of I5NP. In Part B, up to 326 patients will participate at approximately 60 sites; up to 163 patients will be randomized to receive I5NP and up to 163 patients randomized to receive placebo.

Read the detailed description

Although the etiology of DGF is not fully understood and may be multifactorial, the pathophysiology appears to be primarily related to ischemia-reperfusion (IR) injury resulting from organ preservation between the times of harvesting from the donor and reperfusion following vascular reanastomosis in the recipient.

I5NP is a small interfering RNA (siRNA) that is being developed for the prophylaxis of delayed graft function (DGF) in patients receiving renal transplants.

Being tested
I5NP, Saline
Keywords
Delayed Graft Function, Kidney Transplant, Renal Transplant, small interfering ribonucleic acid (siRNA)
Medical subject headings
Delayed Graft Function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • I5NPDrug

    Also called QPI-1002

    Single IV injection of I5NP

    Part A: dose-escalation study; cohort 1 = 0.5 mg/kg; cohort 2 = 1.5 mg/kg; cohort 3 = 5.0 mg/kg; cohort 4 = 10.0 mg/kg

    Part B: 10.0 mg/kg

  • SalineDrug

    Single IV injection of saline

    Part A: dose-escalation study; cohort 1 = 0.5 mg/kg; cohort 2 = 1.5 mg/kg; cohort 3 = 5.0 mg/kg; cohort 4 = 10.0 mg/kg

    Part B: 10.0 mg/kg

Study groups in NCT00802347
Study groupRoleWhat they receive
I5NPExperimentalNot described
Receives: Drug: I5NP
SalinePlacebo comparatorNot described
Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: The outcome measure is safety. Additionally, plasma blood levels will be measured to characterize the PK of I5NP in this patient population. Part B: The outcome measure will be safety and the incidence of delayed graft function.

    Measured: Part A: DSMB review at conclusion of each cohort / Part B: Interim analyses will be performed after the 66th, 130th, and 196th patient enrolled

Secondary outcomes (1)

  1. Part B: Treatment differences in the rate of improvement in renal function over time and treatment differences in the need for renal replacement therapy.

    Measured: Part B: Interim analyses will be performed after the 66th, 130th, and 196th patient enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionNov 2013
  4. Study completionMay 2014

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00802347
Sponsor's protocol ID
QRK.006
Status last verified
Sep 2014
First submitted
2 Dec 2008
Last updated
18 Sep 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing I5NP and Saline in people with Delayed Graft Function and Other Complication of Kidney Transplant, run by Quark Pharmaceuticals at 50 sites in 5 countries.

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 16 inclusion and 14 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 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Germany, Canada, France, Spain. 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?

Part A: The outcome measure is safety. Additionally, plasma blood levels will be measured to characterize the PK of I5NP in this patient population. Part B: The outcome measure will be safety and the incidence of delayed graft function. (time frame: Part A: DSMB review at conclusion of each cohort / Part B: Interim analyses will be performed after the 66th, 130th, and 196th patient enrolled). 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 NCT00802347.

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 18 Sep 2014.

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