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Study to Improve Renal Function After Kidney Transplantation

This study is currently recruiting participants.
Verified December 2011 by Angion Biomedica Corp
Sponsor:
Information provided by (Responsible Party):
Angion Biomedica Corp
ClinicalTrials.gov Identifier:
NCT01286727
First received: January 27, 2011
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Delayed Graft Function
 Drug: BB3
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Pilot Study of BB3 to Improve Renal Function in Patients With Signs and Symptoms of Significant Renal Injury After Kidney Transplantation and at Risk for Dialysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Angion Biomedica Corp:

Primary Outcome Measures:
  • Urine production [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    mean time (days) until production of ≥ 50 cc/H of urine over a 12 hour period


Secondary Outcome Measures:
  • Change from baseline urine production [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Change from baseline urine production (cc/H) at each of the following time points: Day 3, Day 7, Day 14, and Day 28

  • creatinine clearance [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Mean measured 24-hour creatinine clearance at Days 3, 7, 14, and 28

  • Incidence of delayed graft function [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Incidence of delayed graft function (required dialysis due to inadequate renal function during the 7 days after transplantation)

  • Number of dialysis sessions [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Number of dialysis sessions through Day 7, 14, and 28

  • Daily urine output [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Mean total daily urine output through Day 14

  • Mean serum creatinine [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Mean serum creatinine at Days 4, 7, 10, 14, and 28

  • Number of acute rejection episodes [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Number of acute rejection episodes

  • Length of hospitalization following transplantation [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Length of hospitalization following transplantation

  • Biomarkers [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Comparison of biomarkers

  • adverse events, clinical laboratory evaluations, vital signs, ECG results [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Safety assessments include adverse events, clinical laboratory evaluations, vital signs, ECG results.


Estimated Enrollment: 30
Study Start Date: January 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline
Placebo
 Drug: BB3
intravenous drug
Active Comparator: BB3 Drug: BB3
intravenous drug

Detailed Description:

Delayed graft function (DGF) is generally defined as the need for dialysis during the first 7 days after transplantation although the definition can also include failure to improve preexisting renal function. DGF is an important problem in renal allograft transplantation that affects approximately 25% of transplanted cadaveric kidneys. It has generally been observed that delayed graft function has been associated with reduced graft survival. In addition to an association of DGF with graft loss, DGF imposes an economic burden due to prolonged hospitalization and dialysis. The strongest association with occurrence of DGF is ischemia around the time of transplantation. Aside from approaches to minimize ischemia time and use of antibody induction, there are no good specific therapeutic options to prevent or treat delayed graft function. This study is designed to evaluate the safety and activity of an 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females ≥ 18 years of age
  2. Had renal transplantation due to end stage disease requiring chronic dialysis
  3. Study drug can be administered within 28 hours after transplantation
  4. Received kidney from healthy donor or donor with history of diabetes mellitus or hypertension
  5. Donor terminal serum creatinine ≤ 2.2 mg/dL.
  6. No urine output or < 50 cc/H over a 6 to 12 hour period, OR normal urine output following transplantation that diminished to < 50 cc/H over a 6 hour period.
  7. Ultrasound following transplantation demonstrates no structural reason for low urine output.
  8. Dry weight ≤ 100 kg.
  9. Women of child bearing potential have a negative serum pregnancy test prior to transplantation.
  10. 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.
  11. In the opinion of the investigator, the subject is capable of understanding and complying with the protocol.
  12. Subjects must have signed the informed consent document prior to performance of any study related procedure including screening procedure.

Exclusion Criteria:

  1. Subject with normal urine output and not requiring dialysis prior to renal transplantation (i.e., had pre-emptive renal transplantation).
  2. Signs and symptoms of volume depletion.
  3. Recipient of multiple organ transplantation or scheduled for multiple organ transplantation.
  4. Recipient of pediatric en-bloc kidney transplantation.
  5. Recipient of kidney with cold ischemia time > 40 hours
  6. Has measurable donor-specific antibody or positive cross-match requiring deviation from standard immunosuppressive therapy.
  7. 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.
  8. Repeated demonstration of QTc interval >450 ms for males and >470 ms for females on peri-operative and screening ECGs
  9. Concurrent sepsis or active bacterial infection.
  10. 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.
  11. Women of child bearing potential who are breast feeding.
  12. History of positive HIV test.
  13. History of rheumatoid arthritis.
  14. Subjects who require the cytochrome P450 1A2 (CYP1A2) inhibitors, ciprofloxacin and/or fluvoxamine (Luvox®).
  15. Subject is unwilling or unable to comply with the protocol or to cooperate fully with the Investigator or the site personnel.
  16. Subject is not deemed medically stable for the study in the opinion of the Investigator or the subject's primary nephrologist.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286727

Locations
United States, Maryland
Division of Transplant Surgery, University of Maryland School of Medicine, University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Minori Kinjo, MT(ASCP), Ph.D.     410-328-0303     mkinjo@smail.umaryland.edu    
Contact: Ilze Sikorski, RN     410-328-0303     ISikorski@smail.umaryland.edu    
Principal Investigator: Matthew Cooper, MD            
United States, Pennsylvania
Thomas E. Starzl Transplantation Institute, University Of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Laurie K Hope, RN, CRC     412-864-3781     hopelk@upmc.edu    
Contact: Stephenie M Dermont, R.N.     412-864-3781     kiklas@upmc.edu    
Principal Investigator: Ron Shapiro, MD            
Sponsors and Collaborators
Angion Biomedica Corp
Investigators
Principal Investigator: Ron Shapiro, MD Thomas E. Starzl Transplantation Institute, University Of Pittsburgh Medical Center
Principal Investigator: Matthew Cooper, MD Division of Transplant Surgery, University of Maryland School of Medicine
  More Information

No publications provided

Responsible Party: Angion Biomedica Corp
ClinicalTrials.gov Identifier: NCT01286727     History of Changes
Other Study ID Numbers: 001-09, 2R44DK066654
Study First Received: January 27, 2011
Last Updated: December 20, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Delayed Graft Function
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013