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Study to Improve Renal Function After Kidney Transplantation

Primary Purpose

Delayed Graft Function

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BB3
Sponsored by
Angion Biomedica Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delayed Graft Function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • California Institute of Renal Research
  • Medstar Georgetown University Hospital
  • MedStar Washington Hospital Center
  • Division of Transplant Surgery, University of Maryland School of Medicine, University of Maryland Medical Center
  • State University of New York at Buffalo
  • The Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Normal Saline

BB3

Arm Description

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline urine production
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
Mean measured 24-hour creatinine clearance at Days 3, 7, 14, and 28
Incidence of delayed graft function
Incidence of delayed graft function (required dialysis due to inadequate renal function during the 7 days after transplantation)
Number of dialysis sessions
Number of dialysis sessions through Day 7, 14, and 28
Daily urine output
Mean total daily urine output through Day 14
Mean serum creatinine
Mean serum creatinine at Days 4, 7, 10, 14, and 28
Number of acute rejection episodes
Number of acute rejection episodes
Length of hospitalization following transplantation
Length of hospitalization following transplantation
Biomarkers
Comparison of biomarkers
adverse events, clinical laboratory evaluations, vital signs, ECG results
Safety assessments include adverse events, clinical laboratory evaluations, vital signs, ECG results.

Full Information

First Posted
January 27, 2011
Last Updated
May 4, 2015
Sponsor
Angion Biomedica Corp
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01286727
Brief Title
Study to Improve Renal Function After Kidney Transplantation
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Angion Biomedica Corp
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Graft Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
BB3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BB3
Intervention Description
intravenous drug
Primary Outcome Measure Information:
Title
Urine production
Description
mean time (days) until production of ≥ 50 cc/H of urine over a 12 hour period
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Change from baseline urine production
Description
Change from baseline urine production (cc/H) at each of the following time points: Day 3, Day 7, Day 14, and Day 28
Time Frame
28 days
Title
creatinine clearance
Description
Mean measured 24-hour creatinine clearance at Days 3, 7, 14, and 28
Time Frame
28 days
Title
Incidence of delayed graft function
Description
Incidence of delayed graft function (required dialysis due to inadequate renal function during the 7 days after transplantation)
Time Frame
7 days
Title
Number of dialysis sessions
Description
Number of dialysis sessions through Day 7, 14, and 28
Time Frame
28 days
Title
Daily urine output
Description
Mean total daily urine output through Day 14
Time Frame
14 days
Title
Mean serum creatinine
Description
Mean serum creatinine at Days 4, 7, 10, 14, and 28
Time Frame
28 days
Title
Number of acute rejection episodes
Description
Number of acute rejection episodes
Time Frame
28 days
Title
Length of hospitalization following transplantation
Description
Length of hospitalization following transplantation
Time Frame
28 days
Title
Biomarkers
Description
Comparison of biomarkers
Time Frame
28 days
Title
adverse events, clinical laboratory evaluations, vital signs, ECG results
Description
Safety assessments include adverse events, clinical laboratory evaluations, vital signs, ECG results.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weizhong Cai, PhD
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
California Institute of Renal Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Medstar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Division of Transplant Surgery, University of Maryland School of Medicine, University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
State University of New York at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Study to Improve Renal Function After Kidney Transplantation

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