Trial Outcomes & Findings for Imaging Kidney Transplant Rejection Using Ferumoxytol-Enhanced Magnetic Resonance (NCT NCT02006108)

NCT ID: NCT02006108

Last Updated: 2018-05-11

Results Overview

According to the study hypothesis, macrophage infiltration into rejected kidneys will be significantly greater than in healthy kidneys; since macrophages are expected to phagocytose injected iron, there should be a detectable difference in signal intensity between healthy and rejected organs. This can be evaluated using semiquantitative T2\* maps.

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

24 hours to 7 days

Results posted on

2018-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Feraheme Intravenous injection of Feraheme, 5 mg Fe/kg Interventions: Drug: Feraheme Procedure: MR Scan Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging MRI-GE Healthcare 3 Tesla magnet: All patients will undergo
Overall Study STARTED	21
Overall Study MR Imaging	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

overall study population is 21 patients we had 5 pts with rejection and 16 without. This is why the rows differ from overall

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Feraheme n=21 Participants Intravenous injection of Feraheme, 5 mg Fe/kg Interventions: Drug: Feraheme Procedure: MR Scan Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging MRI-GE Healthcare 3 Tesla magnet: All patients will undergo
Age, Categorical <=18 years	14 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=21 Participants
Age, Continuous	17.8 years STANDARD_DEVIATION 2.8 • n=21 Participants
Sex: Female, Male Female	9 Participants n=21 Participants
Sex: Female, Male Male	12 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=21 Participants
Race (NIH/OMB) Asian	2 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=21 Participants
Race (NIH/OMB) White	15 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=21 Participants
Region of Enrollment United States	21 participants n=21 Participants
Number of Patients with Kidney Transplant	21 Participants n=21 Participants
MRI Compatibility	21 Participants n=21 Participants
Drug allergies, specifically against iron compounds	0 Participants n=21 Participants
GFR Rejection	52 ml/min/1.73 m2 STANDARD_DEVIATION 24 • n=5 Participants • overall study population is 21 patients we had 5 pts with rejection and 16 without. This is why the rows differ from overall
GFR Normal	90 ml/min/1.73 m2 STANDARD_DEVIATION 29 • n=16 Participants • overall study population is 21 patients we had 5 pts with rejection and 16 without. This is why the rows differ from overall
Pregnancy	0 Participants n=9 Participants • we checked all female participants for pregnancy and none was pregnant

PRIMARY outcome

Timeframe: 24 hours to 7 days

Population: T2\* value of transplant kidney

Outcome measures

Outcome measures
Measure	Feraheme n=19 Participants Intravenous injection of Feraheme, 5 mg Fe/kg Interventions: Drug: Feraheme Procedure: MR Scan Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging MRI-GE Healthcare 3 Tesla magnet: All patients will undergo
Radiologically Detectable Differences in Signal Intensity Between Healthy and Rejected Kidneys, Measured Using T2* Maps Rejection	31.1 ms (delayed postcontrast scans) Standard Deviation 14.4
Radiologically Detectable Differences in Signal Intensity Between Healthy and Rejected Kidneys, Measured Using T2* Maps No Rejection	23.3 ms (delayed postcontrast scans) Standard Deviation 5.4

SECONDARY outcome

Timeframe: 3 weeks

Population: CD163 positive macrophages

To evaluate our ability to quantify cell-bound iron using the novel QSM sequence, we use histopathological data showing 1) the iron content of renal tissue sampled, and 2) the level of macrophage infiltration of the renal tissue. We will perform iron and macrophage stains in biopsy tissues in order to determine this.

Outcome measures

Outcome measures
Measure	Feraheme n=19 Participants Intravenous injection of Feraheme, 5 mg Fe/kg Interventions: Drug: Feraheme Procedure: MR Scan Feraheme: Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging MRI-GE Healthcare 3 Tesla magnet: All patients will undergo
Correlation of Cell-bound Iron Quantities on QSM Sequences With Macrophage and Iron Stains on Histopathology	0 correlation coefficient

Adverse Events

Feraheme

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Heike E. Daldrup-Link

Stanford University, Department of Radiology

Phone: 650-497-8601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place