Trial Outcomes & Findings for The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes (NCT NCT02915263)
NCT ID: NCT02915263
Last Updated: 2024-05-07
Results Overview
The Utah Early Neuropathy Scale (UENS) was developed specifically to detect and quantify early small-fiber sensory neuropathy and to recognize modest changes in sensory severity and distribution. The UENS scale ranges from 0 (no neuropathy) to 42 (severe small fiber neuropathy). The outcome measure is the UENS score from 7 weeks (final evaluation) minus the UENS score from the baseline visit. A positive value indicates that neuropathy worsened over the course of the trial (a worse outcome), a negative score indicates that neuropathy improved over the course of the trial (a better outcome).
TERMINATED
PHASE2
13 participants
7 weeks after first infusion.
2024-05-07
Participant Flow
Participant milestones
| Measure |
0.9% Sodium Chloride
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The placebo will consist of 0.9% Sodium Chloride per day over 5 days. Participants who are randomized to placebo will receive the same volume as they would if they were randomized to IVIG (i.e.: as if receiving IVIG at 2gm/kg) through a peripheral IV line.
0.9% Sodium Chloride: Sodium Chloride (also known as saline) is a solution of sodium chloride, or salt, and sterile water.
|
IGIV-C
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The treatment will consist of IVIG administered at 2 grams/kg divided over 5 days, with a follow up treatment 3 weeks (+/-3 days) later of IVIG 1gram/kg administered over 2 day (or placebo).
IGIV-C: Gamunex-C \[immune globulin injection (human) 10% caprylate/chromatography purified\] is a sterile solution of human immune globulin protein.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
0.9% Sodium Chloride
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The placebo will consist of 0.9% Sodium Chloride per day over 5 days. Participants who are randomized to placebo will receive the same volume as they would if they were randomized to IVIG (i.e.: as if receiving IVIG at 2gm/kg) through a peripheral IV line.
0.9% Sodium Chloride: Sodium Chloride (also known as saline) is a solution of sodium chloride, or salt, and sterile water.
|
IGIV-C
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The treatment will consist of IVIG administered at 2 grams/kg divided over 5 days, with a follow up treatment 3 weeks (+/-3 days) later of IVIG 1gram/kg administered over 2 day (or placebo).
IGIV-C: Gamunex-C \[immune globulin injection (human) 10% caprylate/chromatography purified\] is a sterile solution of human immune globulin protein.
|
|---|---|---|
|
Overall Study
Covid
|
3
|
2
|
Baseline Characteristics
The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes
Baseline characteristics by cohort
| Measure |
0.9% Sodium Chloride
n=6 Participants
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The placebo will consist of 0.9% Sodium Chloride per day over 5 days. Participants who are randomized to placebo will receive the same volume as they would if they were randomized to IVIG (i.e.: as if receiving IVIG at 2gm/kg) through a peripheral IV line.
0.9% Sodium Chloride: Sodium Chloride (also known as saline) is a solution of sodium chloride, or salt, and sterile water.
|
IGIV-C
n=7 Participants
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The treatment will consist of IVIG administered at 2 grams/kg divided over 5 days, with a follow up treatment 3 weeks (+/-3 days) later of IVIG 1gram/kg administered over 2 day (or placebo).
IGIV-C: Gamunex-C \[immune globulin injection (human) 10% caprylate/chromatography purified\] is a sterile solution of human immune globulin protein.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
39 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
40 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 weeks after first infusion.Population: A total of 3 participants completed treatment with placebo and 4 with IVIG. The remaining participants were unable to continue due to COVID 19 pandemic shutdown of all research activities. Funding was withdrawn at that time and no further studies were completed.
The Utah Early Neuropathy Scale (UENS) was developed specifically to detect and quantify early small-fiber sensory neuropathy and to recognize modest changes in sensory severity and distribution. The UENS scale ranges from 0 (no neuropathy) to 42 (severe small fiber neuropathy). The outcome measure is the UENS score from 7 weeks (final evaluation) minus the UENS score from the baseline visit. A positive value indicates that neuropathy worsened over the course of the trial (a worse outcome), a negative score indicates that neuropathy improved over the course of the trial (a better outcome).
Outcome measures
| Measure |
0.9% Sodium Chloride
n=3 Participants
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The placebo will consist of 0.9% Sodium Chloride per day over 5 days. Participants who are randomized to placebo will receive the same volume as they would if they were randomized to IVIG (i.e.: as if receiving IVIG at 2gm/kg) through a peripheral IV line.
0.9% Sodium Chloride: Sodium Chloride (also known as saline) is a solution of sodium chloride, or salt, and sterile water.
|
IGIV-C
n=4 Participants
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The treatment will consist of IVIG administered at 2 grams/kg divided over 5 days, with a follow up treatment 3 weeks (+/-3 days) later of IVIG 1gram/kg administered over 2 day (or placebo).
IGIV-C: Gamunex-C \[immune globulin injection (human) 10% caprylate/chromatography purified\] is a sterile solution of human immune globulin protein.
|
|---|---|---|
|
Change in Sensory Neuropathy as Measured by the Utah Early Neuropathy Score (UENS).
|
-1.5 units on a scale
Standard Deviation 10.7
|
-3.9 units on a scale
Standard Deviation 12.4
|
PRIMARY outcome
Timeframe: 7 weeks after first infusionThe visual analog scale (VAS) of pain allows for quantification of neuropathic pain. The VAS pain scale is a line with markings that range from 0 (no pain) to 10 (worse pain), with whole digit intervals (thus an 11 point scale). This outcome measure is the VAS pain score at the final visit (7 weeks after first infusion) minus the VAS pain score at the baseline visit. A positive result indicates that pain increased over the course of the study (a worse outcome), a negative result indicates that pain improved over the course of the trial (a better outcome).
Outcome measures
| Measure |
0.9% Sodium Chloride
n=3 Participants
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The placebo will consist of 0.9% Sodium Chloride per day over 5 days. Participants who are randomized to placebo will receive the same volume as they would if they were randomized to IVIG (i.e.: as if receiving IVIG at 2gm/kg) through a peripheral IV line.
0.9% Sodium Chloride: Sodium Chloride (also known as saline) is a solution of sodium chloride, or salt, and sterile water.
|
IGIV-C
n=4 Participants
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The treatment will consist of IVIG administered at 2 grams/kg divided over 5 days, with a follow up treatment 3 weeks (+/-3 days) later of IVIG 1gram/kg administered over 2 day (or placebo).
IGIV-C: Gamunex-C \[immune globulin injection (human) 10% caprylate/chromatography purified\] is a sterile solution of human immune globulin protein.
|
|---|---|---|
|
Change in Neuropathic Pain Severity as Measured by the Pain Visual Analogue Scores (VAS).
|
-1.1 units on a scale
Standard Deviation 2.2
|
-1.6 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 7 weeks after first infusionPopulation: The change in nerve fiber density.
Skin biopsies will be evaluated by measuring the Intra-epidermal nerve fiber density. Nerve fiber density is measured in the number of nerve fibers per millimeter. This outcome measure is the nerve fiber density at the final visit (7 weeks after the initial infusion) minus the nerve fiber density from the baseline visit. A positive result indicates that nerve fiber density increased over the course of the study (a better outcome), a negative result indicates that nerve fiber density decreased over the course of the trial (a worse outcome).
Outcome measures
| Measure |
0.9% Sodium Chloride
n=3 Participants
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The placebo will consist of 0.9% Sodium Chloride per day over 5 days. Participants who are randomized to placebo will receive the same volume as they would if they were randomized to IVIG (i.e.: as if receiving IVIG at 2gm/kg) through a peripheral IV line.
0.9% Sodium Chloride: Sodium Chloride (also known as saline) is a solution of sodium chloride, or salt, and sterile water.
|
IGIV-C
n=4 Participants
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The treatment will consist of IVIG administered at 2 grams/kg divided over 5 days, with a follow up treatment 3 weeks (+/-3 days) later of IVIG 1gram/kg administered over 2 day (or placebo).
IGIV-C: Gamunex-C \[immune globulin injection (human) 10% caprylate/chromatography purified\] is a sterile solution of human immune globulin protein.
|
|---|---|---|
|
Change in Neuropathy Severity as Measured by Skin Biopsies.
|
-0.6 fibers/mm
Standard Deviation 2.5
|
-0.3 fibers/mm
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 7 weeks after first infusionPopulation: A change in the heart rate variability during paced breathing.
The standardized autonomic nervous system testing evaluates the heart rate variability to paced breathing. Heart rate variability is reported in beats per minutes. The outcome measure is the heart rate variability at the final visit (7 weeks after initial infusion) minus the heart rate variability of the baseline visit. A positive result indicates an increase in heart rate variability (a better outcome), a negative result indicates a decrease in heart rate variability (a worse outcome).
Outcome measures
| Measure |
0.9% Sodium Chloride
n=3 Participants
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The placebo will consist of 0.9% Sodium Chloride per day over 5 days. Participants who are randomized to placebo will receive the same volume as they would if they were randomized to IVIG (i.e.: as if receiving IVIG at 2gm/kg) through a peripheral IV line.
0.9% Sodium Chloride: Sodium Chloride (also known as saline) is a solution of sodium chloride, or salt, and sterile water.
|
IGIV-C
n=4 Participants
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The treatment will consist of IVIG administered at 2 grams/kg divided over 5 days, with a follow up treatment 3 weeks (+/-3 days) later of IVIG 1gram/kg administered over 2 day (or placebo).
IGIV-C: Gamunex-C \[immune globulin injection (human) 10% caprylate/chromatography purified\] is a sterile solution of human immune globulin protein.
|
|---|---|---|
|
Change in Autonomic Neuropathy as Measured by Standardized Autonomic Nervous System Testing.
|
2.1 beats/minute
Standard Deviation 3.2
|
2.5 beats/minute
Standard Deviation 3.4
|
Adverse Events
0.9% Sodium Chloride
IGIV-C
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.9% Sodium Chloride
n=3 participants at risk
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The placebo will consist of 0.9% Sodium Chloride per day over 5 days. Participants who are randomized to placebo will receive the same volume as they would if they were randomized to IVIG (i.e.: as if receiving IVIG at 2gm/kg) through a peripheral IV line.
0.9% Sodium Chloride: Sodium Chloride (also known as saline) is a solution of sodium chloride, or salt, and sterile water.
|
IGIV-C
n=4 participants at risk
The study will include a total 20 individuals. Subjects will be randomized equally to treatment or placebo. The treatment will consist of IVIG administered at 2 grams/kg divided over 5 days, with a follow up treatment 3 weeks (+/-3 days) later of IVIG 1gram/kg administered over 2 day (or placebo).
IGIV-C: Gamunex-C \[immune globulin injection (human) 10% caprylate/chromatography purified\] is a sterile solution of human immune globulin protein.
|
|---|---|---|
|
General disorders
Infusion reactions
|
33.3%
1/3 • Number of events 1 • 2 months
Adverse events recorded at the time of infusion, during interim visits and on phone screens between visits.
|
50.0%
2/4 • Number of events 2 • 2 months
Adverse events recorded at the time of infusion, during interim visits and on phone screens between visits.
|
Additional Information
Christopher Gibbons MD
Beth Israel Deaconess Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place