Study on Delayed Graft Function Using Paired Kidneys

NCT01561599 | Unknown Phase 2 DMC

• 3 other identifiers: 004-092010-019243-192R44DK078455-02
• Study Type: interventional
• Target: 12
• Locations: 3 countries
• Sites: 3

Brief Summary

The study is designed to evaluate the safety and efficacy of an intravenously administered drug in recipients of kidneys from cardiac death donors who are risk for developing delayed graft function.

Conditions

Delayed Graft Function

Keywords

hepatocyte growth factor mimetic; hepatocyte growth factor(HGF); Delayed Graft Function (DGF); Kidney transplantation

Outcome Measures

Primary Outcomes (1)

• creatinine clearance

  The primary analysis to assess the activity of BB3 compared to placebo will be the mean difference in creatinine clearance over time using selective 24-hour urine collections from the transplanted kidney from the first infusion of study drug through day 7 post-transplant.

  7 days

Secondary Outcomes (9)

• Urine production

  28 days

• Creatinine clearance

  28 days

• Incidence of delayed graft function

  7 days

• Number of dialysis sessions

  28 days

• Mean total daily urine output

  14 days

Study Arms (2)

Normal saline

PLACEBO COMPARATOR

Placebo

Drug: Normal Saline

BB3

ACTIVE COMPARATOR

Small molecule mimetic of hepatocyte growth factor/scatter factor

Drug: BB3

Interventions

BB3 DRUG

Daily intravenous administration of 2mg/kg for 4 days

BB3

Normal Saline DRUG

Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.

Normal saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must sign the informed consent document prior to performance of any study related procedure including the Screening procedure.
• Males and females ≥ 18 years of age.
• Had renal transplantation due to end stage disease requiring chronic dialysis.
• Study drug can be administered within 6 to 36 hours after transplantation.
• Received kidney from donor after cardiac death.
• DCD kidney fulfills the clinical site's criteria for transplantation.
• Creatinine clearance from the transplanted kidney over a 2-hour collection period is \<10 mL/min, OR no urine output OR average urine output of \< 50 cc/H over 8 or more consecutive hours,, OR normal urine output following transplantation that diminished to average of \< 50 cc/H over 8 or more consecutive hours, OR Creatinine reduction ratio 24 hours after transplantation to pre-transplantation is \< 30%.
• Dry weight ≤ 100 kg.
• Women of child bearing potential have a negative pregnancy test prior to transplantation.
• Women of child bearing potential (including perimenopausal women who have had a menstrual period within 1 year) must agree to use 2 forms of effective birth control regimen (at least one-barrier method) during the 28-day study period. Men must agree to use condoms during the study period; a condom with spermicide is considered a single barrier.
• In the opinion of the Investigator, the subject is capable of understanding and complying with the protocol.

You may not qualify if:

• Mean arterial pressure \<40 mmHg or cardiac index \<1.8 L/min/m2.
• Recipient of multiple organ transplantation or scheduled for multiple organ transplantation.
• Recipient of kidney from a pediatric donor age 10 years or less.
• Recipient age \> 75 years.
• Patients with ASA 4 or 5
• Patients with chronic obstructive pulmonary disease (COPD) GOLD IV
• Has measurable donor-specific antibody or positive cross-match requiring deviation from standard immunosuppressive therapy.
• Currently participating in or has participated in an investigational drug or medical device study within 30 days or five half-lives, whichever is longer, prior to enrolment into this study.
• Concurrent sepsis or active bacterial infection.
• Have an active malignancy or history of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.
• Women of child bearing potential who is breast feeding.
• History of positive HIV test.
• History of rheumatoid arthritis.
• History of proliferative retinopathy or laser surgery for retinopathy.
• Subjects who have a penicillin allergy.

Sponsors & Collaborators

• Angion Biomedica Corp: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

Maastricht University Medical Center

Minderbroedersberg, Maastricht, 6211 LK, Netherlands

Location

Hospital Clínico San Carlos

San Carlos, Madrid, 28001, Spain

Location

The Newcastle Upon Tyne Hospital

Newcastle, Metropolitan County of Tyne and Wear, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Delayed Graft Function; Deafness, Autosomal Recessive 39

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: March 23, 2012
• Study Start: August 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 22, 2016

Record last verified: 2016-02

Locations

NL (1); ES (1); GB (1)