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Study to Improve Renal Function After Kidney Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Angion Biomedica Corp
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Angion Biomedica Corp
ClinicalTrials.gov Identifier:
NCT01286727
First received: January 27, 2011
Last updated: October 6, 2014
Last verified: October 2014

January 27, 2011
October 6, 2014
January 2010
February 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01286727 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Study to Improve Renal Function After Kidney Transplantation
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Delayed Graft Function
Drug: BB3
intravenous drug
  • Placebo Comparator: Normal Saline
    Placebo
  • Active Comparator: BB3
    Intervention: Drug: BB3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
April 2015
February 2015   (final data collection date for primary outcome measure)

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 36 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 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%.
  7. Reason for low urine output is unlikely due to structural changes. If clinically indicated, an ultrasound will be performed
  8. Dry weight to< 120kg and BMI <35
  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. Concurrent sepsis or active bacterial infection.
  9. 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.
  10. Women of child bearing potential who are breast feeding.
  11. History of positive HIV test.
  12. History of rheumatoid arthritis.
  13. Subjects who require the cytochrome P450 1A2 (CYP1A2) inhibitors, ciprofloxacin and/or fluvoxamine (Luvox®)
  14. Subject is unwilling or unable to comply with the protocol or to cooperate fully with the Investigator or the site personnel.
  15. Subject is not deemed medically stable for the study in the opinion of the Investigator or the subject's primary nephrologist.
Both
18 Years and older
No
Contact: Weizhong Cai, PhD 516-326-1200 wcai@angion.com
Contact: Itzhak D. Goldberg, MD, FACR 516-869-6400 igoldberg@angion.com
United States
 
NCT01286727
001-09, 2R44DK066654
Yes
Angion Biomedica Corp
Angion Biomedica Corp
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Director: Weizhong Cai, PhD Sponsor GmbH
Angion Biomedica Corp
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP