Study on Delayed Graft Function Using Paired Kidneys
|ClinicalTrials.gov Identifier: NCT01561599|
Recruitment Status : Unknown
Verified February 2016 by Angion Biomedica Corp.
Recruitment status was: Active, not recruiting
First Posted : March 23, 2012
Last Update Posted : February 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Delayed Graft Function||Drug: BB3 Drug: Normal Saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pilot Study of BB3 to Improve Renal Function in Patients With Signs and Symptoms of Significant Renal Injury After Kidney Transplantation From Donors After Cardiac Death|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||May 2016|
Placebo Comparator: Normal saline
Drug: Normal Saline
Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.
Active Comparator: BB3
Small molecule mimetic of hepatocyte growth factor/scatter factor
Daily intravenous administration of 2mg/kg for 4 days
- creatinine clearance [ Time Frame: 7 days ]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.
- Urine production [ Time Frame: 28 days ]Median time (days) until production of ≥1 litre urine over a 24-hour period, i.e. median number of days following the first infusion of study drug until the first day (08:00 - 08:00) that urine production was ≥1 litre over a 24-hour period.
- Creatinine clearance [ Time Frame: 28 days ]Calculated creatinine clearance at days 14 and 28
- Incidence of delayed graft function [ Time Frame: 7 days ]Incidence of delayed graft function (required dialysis due to inadequate renal function during the first 7 days after transplantation).
- Number of dialysis sessions [ Time Frame: 28 days ]Number of dialysis sessions through day 7, 14, and 28
- Mean total daily urine output [ Time Frame: 14 days ]Mean total daily urine output through day 14
- Daily serum creatinine [ Time Frame: 7 days ]Daily serum creatinine at days 1 to 7
- Mean serum creatinine [ Time Frame: 28 days ]Mean serum creatinine at days 4, 7, 10, 14, and 28
- Length of hospitalization following transplantation [ Time Frame: 28 days ]Length of hospitalization following transplantation
- Follow-up on graft survival and function [ Time Frame: 12 months ]Results of the 6- and 12-month follow-up on graft survival and function will be summarized as an addendum to the final clinical study report
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561599
|Maastricht University Medical Center|
|Minderbroedersberg, Maastricht, Netherlands, 6211 LK|
|Hospital Clínico San Carlos|
|San Carlos, Madrid, Spain, 28001|
|The Newcastle Upon Tyne Hospital|
|Newcastle, metropolitan county of Tyne and Wear, United Kingdom, NE7 7DN|