Study to Improve Renal Function After Kidney Transplantation

NCT01286727 | Unknown Phase 2 DMC

• 2 other identifiers: 001-092R44DK066654
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief Summary

The objective of the study is to evaluate the safety and activity of a investigational drug in improving renal function in patients who have undergone renal transplantation and have signs and symptoms of significant renal injury and are at risk for dialysis.

Conditions

Delayed Graft Function

Outcome Measures

Primary Outcomes (1)

• Urine production

  mean time (days) until production of ≥ 50 cc/H of urine over a 12 hour period

  28 days

Secondary Outcomes (10)

• Change from baseline urine production

  28 days

• creatinine clearance

  28 days

• Incidence of delayed graft function

  7 days

• Number of dialysis sessions

  28 days

• Daily urine output

  14 days

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

Placebo

BB3

ACTIVE COMPARATOR

Drug: BB3

Interventions

BB3 DRUG

intravenous drug

BB3

Eligibility Criteria

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

You may qualify if:

• Males and females ≥ 18 years of age
• Had renal transplantation due to end stage disease requiring chronic dialysis
• Study drug can be administered within 36 hours after transplantation
• Received kidney from healthy donor or donor with history of diabetes mellitus or hypertension
• Donor terminal serum creatinine ≤ 2.2 mg/dL.
• 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 at 24 hours after transplantation to pre-transplantation is \< 30%.
• Reason for low urine output is unlikely due to structural changes. If clinically indicated, an ultrasound will be performed
• Dry weight to\< 120kg and BMI \<35
• Women of child bearing potential have a negative serum 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 28-day study period.
• In the opinion of the investigator, the subject is capable of understanding and complying with the protocol.
• Subjects must have signed the informed consent document prior to performance of any study related procedure including screening procedure.

You may not qualify if:

• Subject with normal urine output and not requiring dialysis prior to renal transplantation (i.e., had pre-emptive renal transplantation).
• Signs and symptoms of volume depletion.
• Recipient of multiple organ transplantation or scheduled for multiple organ transplantation.
• Recipient of pediatric en-bloc kidney transplantation.
• Recipient of kidney with cold ischemia time \> 40 hours
• 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 enrollment 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 are breast feeding.
• History of positive HIV test.
• History of rheumatoid arthritis.
• Subjects who require the cytochrome P450 1A2 (CYP1A2) inhibitors, ciprofloxacin and/or fluvoxamine (Luvox®)
• Subject is unwilling or unable to comply with the protocol or to cooperate fully with the Investigator or the site personnel.
• Subject is not deemed medically stable for the study in the opinion of the Investigator or the subject's primary nephrologist.

Sponsors & Collaborators

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

Study Sites (6)

California Institute of Renal Research

San Diego, California, 92123, United States

Location

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Division of Transplant Surgery, University of Maryland School of Medicine, University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

State University of New York at Buffalo

Buffalo, New York, 14215, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Weizhong Cai, PhD

  Sponsor GmbH

  STUDY DIRECTOR

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: January 27, 2011
• First Posted: January 31, 2011
• Study Start: February 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2016
• Last Updated: May 5, 2015

Record last verified: 2014-10

Locations

US (6)