Trial Outcomes & Findings for Phase II Study, Evaluation of Safety and Efficacy of IdeS in Chronic Kidney Disease (NCT NCT02224820)
NCT ID: NCT02224820
Last Updated: 2017-03-03
Results Overview
Efficacy was defined as the IdeS dosing scheme in the majority of the patients resulting in human leucocyte antigen (HLA) antibody levels which are acceptable for transplantation, measured as mean fluorescent intensity (MFI) of less than 1100, within 24 hours from dosing. MFI was determined by single antigen bead (SAB) assay and detection of complement fixating ability (CIq Screen) in serum.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
24 hours
Results posted on
2017-03-03
Participant Flow
The study was performed at a medical clinic, the Department of Transplantat Surgery, Uppsala, SE between 10 Jun 2014 and 13 Feb 2015. The patients had chronic kidney disease, were in dialysis and on the waiting list for transplantation. (Transplantation was not part of the protocol).
In total, 10 patients were assessed for eligibility. One patient declined to participate and one patient was not available for recieving information about the study. Eight patients were enrolled and started treatment.
Participant milestones
| Measure |
Intravenous IdeS
One or two doses of IdeS in ascending doses.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study, Evaluation of Safety and Efficacy of IdeS in Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Intravenous IdeS
n=8 Participants
One or two doses of IdeS in ascending doses
IdeS
|
|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Gender
Female
|
5 Participants
n=5 Participants
|
|
Gender
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Weight (kg)
|
74.5 kg
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
BMI
|
25.1 kg/mg^2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Height
|
172.3 cm
STANDARD_DEVIATION 9.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursEfficacy was defined as the IdeS dosing scheme in the majority of the patients resulting in human leucocyte antigen (HLA) antibody levels which are acceptable for transplantation, measured as mean fluorescent intensity (MFI) of less than 1100, within 24 hours from dosing. MFI was determined by single antigen bead (SAB) assay and detection of complement fixating ability (CIq Screen) in serum.
Outcome measures
| Measure |
Intravenous IdeS
n=8 Participants
One or two doses of IdeS in ascending doses.
|
|---|---|
|
Efficacy
|
372 MFI
Interval 83.0 to 978.0
|
SECONDARY outcome
Timeframe: 9 weeksAdverse events (all clinical laboratory tests, vital signs and ECG jugded as clinically significant were reported as AEs)
Outcome measures
| Measure |
Intravenous IdeS
n=8 Participants
One or two doses of IdeS in ascending doses.
|
|---|---|
|
Safety
|
76 Adverse events
|
SECONDARY outcome
Timeframe: Up to day 64IgG cleavage and regeneration measured by ELISA
Outcome measures
| Measure |
Intravenous IdeS
n=8 Participants
One or two doses of IdeS in ascending doses.
|
|---|---|
|
Pharmacodynamics
|
30 µg/mL
Standard Deviation 3
|
SECONDARY outcome
Timeframe: Up to 64 daysPresence of Anti-Drug Antibodies formation in serum throughout a 64 day period
Outcome measures
| Measure |
Intravenous IdeS
n=8 Participants
One or two doses of IdeS in ascending doses.
|
|---|---|
|
Immunogenicity
|
8 participants
|
SECONDARY outcome
Timeframe: Up to 21 daysIdeS T1/2 in alpha phase. One patient who interrupted dose was excluded.
Outcome measures
| Measure |
Intravenous IdeS
n=7 Participants
One or two doses of IdeS in ascending doses.
|
|---|---|
|
Pharmacokinetics
|
5 h
Interval 2.0 to 11.0
|
Adverse Events
Intravenous IdeS
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intravenous IdeS
n=8 participants at risk
One or two doses of IdeS in ascending doses.
|
|---|---|
|
Infections and infestations
Pneumonia
|
25.0%
2/8 • Number of events 2 • From the time of admission until last visit, 64 days after treatment.
|
|
Infections and infestations
Suspected upper respiratory infection
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Increased mucos production
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
Other adverse events
| Measure |
Intravenous IdeS
n=8 participants at risk
One or two doses of IdeS in ascending doses.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
25.0%
2/8 • Number of events 2 • From the time of admission until last visit, 64 days after treatment.
|
|
Infections and infestations
Oral candidiasis
|
25.0%
2/8 • Number of events 2 • From the time of admission until last visit, 64 days after treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Infections and infestations
Herpes simplex infection
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Infections and infestations
Hordeolum
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Infections and infestations
Influenza
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Infections and infestations
Tonsillitis
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Investigations
Alanine aminotransferas increased
|
25.0%
2/8 • Number of events 2 • From the time of admission until last visit, 64 days after treatment.
|
|
Investigations
Aspartate aminotransferas increased
|
25.0%
2/8 • Number of events 2 • From the time of admission until last visit, 64 days after treatment.
|
|
Investigations
Blood phosphorus increased
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Investigations
C-reactive proteine increased
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Investigations
Donor specific antibody present
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Investigations
Weight increased
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2 • From the time of admission until last visit, 64 days after treatment.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • Number of events 2 • From the time of admission until last visit, 64 days after treatment.
|
|
Gastrointestinal disorders
Dyspesia
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
General disorders
Infusion site pain
|
25.0%
2/8 • Number of events 2 • From the time of admission until last visit, 64 days after treatment.
|
|
General disorders
Pyrexia
|
25.0%
2/8 • Number of events 2 • From the time of admission until last visit, 64 days after treatment.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
General disorders
Feeling cold
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
General disorders
Feeling hot
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
2/8 • Number of events 2 • From the time of admission until last visit, 64 days after treatment.
|
|
Blood and lymphatic system disorders
Leucocytosis
|
25.0%
2/8 • Number of events 2 • From the time of admission until last visit, 64 days after treatment.
|
|
Blood and lymphatic system disorders
Leucopenia
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
2/8 • Number of events 2 • From the time of admission until last visit, 64 days after treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 2 • From the time of admission until last visit, 64 days after treatment.
|
|
Nervous system disorders
Dizziness postural
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Nervous system disorders
Dysgeuisa
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Vascular disorders
Flushing
|
25.0%
2/8 • Number of events 2 • From the time of admission until last visit, 64 days after treatment.
|
|
Vascular disorders
Haematoma
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Vascular disorders
Thrombosis
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Eye disorders
Scleral haemorrage
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Eye disorders
Visual impairment
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Immune system disorders
Kidney transplant rejection
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Renal and urinary disorders
Haematuria
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1 • From the time of admission until last visit, 64 days after treatment.
|
Additional Information
Dr. Tomas Lorant
Dept of Transplant Surgery, Uppsala University Hospital
Phone: +46 70 677 29 01
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place