Trial Outcomes & Findings for Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy (NCT NCT04042623)

NCT ID: NCT04042623

Last Updated: 2022-02-10

Results Overview

Measured by the number of patients with AEs

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 14 weeks
• Results posted on: 2022-02-10

Participant Flow

Participant milestones

Measure	Treatment With AVB-S6-500 The subject received a single dose of AVB-S6-500 at 10 mg/kg (total dose 670 mg)
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy

Baseline characteristics by cohort

Measure	Treatment With AVB-S6-500 n=1 Participants The subject received a single dose of AVB-S6-500 at 10 mg/kg (total dose 670 mg)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	1 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
Region of Enrollment Ukraine	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 weeks

Measured by the number of patients with AEs

Outcome measures

Measure	Treatment With AVB-S6-500 n=1 Participants The subject received a single dose of AVB-S6-500 at 10 mg/kg (total dose 670 mg)
Incidence of Adverse Events (AEs)	1 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The subject discontinued the study before data were collected, hence the outcome measure was not analyzed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 weeks

Population: The subject discontinued the study before data were collected, hence the outcome measure was not analyzed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 weeks

Population: The subject discontinued the study before data were collected, hence the outcome measure was not analyzed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 weeks

Population: The subject discontinued the study before data were collected, hence the outcome measure was not analyzed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 weeks

Population: The subject discontinued the study before data were collected, hence the outcome measure was not analyzed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 weeks

Population: The subject discontinued the study before data were collected, hence the outcome measure was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 weeks

Population: The subject discontinued the study before data were collected, hence the outcome measure was not analyzed.

The number of participants with anti-AVB-S6-500 antibodies

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 weeks

Population: The subject discontinued the study before data were collected, hence the outcome measure was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Samples were not analyzed because the study was terminated by the Sponsor.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Samples were not analyzed because the study was terminated by the Sponsor.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Samples were not analyzed because the study was terminated by the Sponsor.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Samples were not analyzed because the study was terminated by the Sponsor.

Outcome measures

Outcome data not reported

Adverse Events

Treatment With AVB-S6-500

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment With AVB-S6-500 n=1 participants at risk The subject received a single dose of AVB-S6-500 at 10 mg/kg (total dose 670 mg)
Vascular disorders Decreased blood pressure	100.0% 1/1 • Number of events 1 • The adverse events data were collected over 1 month period: the subject consented to participate in this study on 11-Feb-2020. On 12-Mar-2020, AVB-S6-500 10 mg/kg (total dose 670 mg) was administered intravenously . The subject did not receive any subsequent doses of AVB-S6-500, nor did she complete the study. The subject underwent post-treatment assessments through telephone contact, as in-person visits were limited due to COVID. The date of early study discontinuation is noted as 06-Apr-2020.
General disorders Rigor	100.0% 1/1 • Number of events 1 • The adverse events data were collected over 1 month period: the subject consented to participate in this study on 11-Feb-2020. On 12-Mar-2020, AVB-S6-500 10 mg/kg (total dose 670 mg) was administered intravenously . The subject did not receive any subsequent doses of AVB-S6-500, nor did she complete the study. The subject underwent post-treatment assessments through telephone contact, as in-person visits were limited due to COVID. The date of early study discontinuation is noted as 06-Apr-2020.
Musculoskeletal and connective tissue disorders Feeling heavy (heaviness) in the back	100.0% 1/1 • Number of events 1 • The adverse events data were collected over 1 month period: the subject consented to participate in this study on 11-Feb-2020. On 12-Mar-2020, AVB-S6-500 10 mg/kg (total dose 670 mg) was administered intravenously . The subject did not receive any subsequent doses of AVB-S6-500, nor did she complete the study. The subject underwent post-treatment assessments through telephone contact, as in-person visits were limited due to COVID. The date of early study discontinuation is noted as 06-Apr-2020.

Additional Information

Dr. Reshma Rangwala, Chief Medical Officer

Aravive

Phone: 936-355-1910

Email: rrangwala@aravive.com

Results disclosure agreements

• Principal investigator is a sponsor employee Per protocol, data are the property of the sponsor and cannot be published without prior authorization from the sponsor, but data and publication thereof will not be unduly withheld. However, since the study was terminated, there are no results to be published.
• Publication restrictions are in place

Restriction type: OTHER