Trial Outcomes & Findings for A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD) (NCT NCT06468826)
NCT ID: NCT06468826
Last Updated: 2026-03-25
Results Overview
Cmax was obtained using noncompartmental analysis.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose
Results posted on
2026-03-25
Participant Flow
This study was conducted as a multicenter study in the United States between 18 June 2024 and 05 October 2024.
Participants were assigned to one of two groups: participants with normal renal function (Group 1) and participants with ESRD requiring hemodialysis (HD) (Group 2). Group 1 received a single dose of avacopan on Day 1. In Group 2, avacopan was given on Day 1 of Period 1 and Day 1 of Period 2. Each period lasted 18 days.
Participant milestones
| Measure |
Group 2: ESRD Requiring HD
Participants in Group 2 received a single dose of avacopan in each of the two treatment periods: Before HD on Day 1 of Period 1 and after HD on Day 1 of Period 2. Each period lasted 18 days.
|
Group 1: Normal Renal Function
Participants in Group 1 received a single dose of avacopan on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
Entered Period 2
|
7
|
0
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD)
Baseline characteristics by cohort
| Measure |
Group 1: Normal Renal Function
n=6 Participants
Participants in Group 1 received a single dose of avacopan on Day 1.
|
Group 2: ESRD Requiring HD
n=7 Participants
Participants in Group 2 received a single dose of avacopan in each of the two treatment periods: Before HD on Day 1 of Period 1 and after HD on Day 1 of Period 2. Each period lasted 18 days.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 6.06 • n=138 Participants
|
51.6 years
STANDARD_DEVIATION 8.08 • n=62 Participants
|
53.4 years
STANDARD_DEVIATION 7.22 • n=123 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=138 Participants
|
6 Participants
n=62 Participants
|
11 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=138 Participants
|
6 Participants
n=62 Participants
|
12 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=138 Participants
|
5 Participants
n=62 Participants
|
8 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=138 Participants
|
2 Participants
n=62 Participants
|
5 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdosePopulation: The pharmacokinetic (PK) population included all participants who received at least 1 dose of avacopan and had evaluable PK data.
Cmax was obtained using noncompartmental analysis.
Outcome measures
| Measure |
Group 1: Normal Renal Function
n=6 Participants
Participants in Group 1 received a single dose of avacopan on Day 1.
|
Group 2; Period 1: ESRD Requiring HD (On-HD)
n=7 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 in treatment Period 1 while participants were on HD.
|
Group 2; Period 2: ESRD Requiring HD (Off-HD)
n=7 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 during treatment Period 2, when they were off HD.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Avacopan
|
105 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22.8
|
86.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 51.0
|
108 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 34.8
|
PRIMARY outcome
Timeframe: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdosePopulation: The PK population included all participants who received at least 1 dose of avacopan and had evaluable PK data.
Cmax was obtained using noncompartmental analysis.
Outcome measures
| Measure |
Group 1: Normal Renal Function
n=6 Participants
Participants in Group 1 received a single dose of avacopan on Day 1.
|
Group 2; Period 1: ESRD Requiring HD (On-HD)
n=7 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 in treatment Period 1 while participants were on HD.
|
Group 2; Period 2: ESRD Requiring HD (Off-HD)
n=7 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 during treatment Period 2, when they were off HD.
|
|---|---|---|---|
|
Cmax of Metabolite M1
|
25.6 ng/mL
Geometric Coefficient of Variation 12.6
|
17.2 ng/mL
Geometric Coefficient of Variation 25.3
|
16.8 ng/mL
Geometric Coefficient of Variation 24.6
|
PRIMARY outcome
Timeframe: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdosePopulation: The PK population included all participants who received at least 1 dose of avacopan and had evaluable PK data.
AUClast was obtained using noncompartmental analysis.
Outcome measures
| Measure |
Group 1: Normal Renal Function
n=6 Participants
Participants in Group 1 received a single dose of avacopan on Day 1.
|
Group 2; Period 1: ESRD Requiring HD (On-HD)
n=7 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 in treatment Period 1 while participants were on HD.
|
Group 2; Period 2: ESRD Requiring HD (Off-HD)
n=7 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 during treatment Period 2, when they were off HD.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Avacopan
|
838 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 44.5
|
661 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 53.9
|
945 hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 49.0
|
PRIMARY outcome
Timeframe: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdosePopulation: The PK population included all participants who received at least 1 dose of avacopan and had evaluable PK data.
AUClast was obtained using noncompartmental analysis.
Outcome measures
| Measure |
Group 1: Normal Renal Function
n=6 Participants
Participants in Group 1 received a single dose of avacopan on Day 1.
|
Group 2; Period 1: ESRD Requiring HD (On-HD)
n=7 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 in treatment Period 1 while participants were on HD.
|
Group 2; Period 2: ESRD Requiring HD (Off-HD)
n=7 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 during treatment Period 2, when they were off HD.
|
|---|---|---|---|
|
AUClast of Metabolite M1
|
456 h*ng/mL
Geometric Coefficient of Variation 29.2
|
277 h*ng/mL
Geometric Coefficient of Variation 21.3
|
292 h*ng/mL
Geometric Coefficient of Variation 28.4
|
PRIMARY outcome
Timeframe: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdosePopulation: The PK population included all participants who received at least 1 dose of avacopan and had evaluable PK data. Only participants with available data were included in this outcome measure.
AUCinf was obtained using noncompartmental analysis.
Outcome measures
| Measure |
Group 1: Normal Renal Function
n=6 Participants
Participants in Group 1 received a single dose of avacopan on Day 1.
|
Group 2; Period 1: ESRD Requiring HD (On-HD)
n=6 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 in treatment Period 1 while participants were on HD.
|
Group 2; Period 2: ESRD Requiring HD (Off-HD)
n=1 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 during treatment Period 2, when they were off HD.
|
|---|---|---|---|
|
AUC From Time Zero to Infinity (AUCinf) of Avacopan
|
922 h*ng/mL
Geometric Coefficient of Variation 44.9
|
666 h*ng/mL
Geometric Coefficient of Variation 53.3
|
NA h*ng/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variation cannot be calculated for a single participant.
|
PRIMARY outcome
Timeframe: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36 hours, Days 3,4,5,6,7,8,12,15, and 18 postdosePopulation: The PK population included all participants who received at least 1 dose of avacopan and had evaluable PK data. Only participants with available data were included in this outcome measure.
AUCinf was obtained using noncompartmental analysis.
Outcome measures
| Measure |
Group 1: Normal Renal Function
n=5 Participants
Participants in Group 1 received a single dose of avacopan on Day 1.
|
Group 2; Period 1: ESRD Requiring HD (On-HD)
n=6 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 in treatment Period 1 while participants were on HD.
|
Group 2; Period 2: ESRD Requiring HD (Off-HD)
n=3 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 during treatment Period 2, when they were off HD.
|
|---|---|---|---|
|
AUCinf of Metabolite M1
|
545 h*ng/mL
Geometric Coefficient of Variation 36.1
|
343 h*ng/mL
Geometric Coefficient of Variation 17.9
|
422 h*ng/mL
Geometric Coefficient of Variation 20.1
|
PRIMARY outcome
Timeframe: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36, and 48 hours postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36, and 48 hours postdosePopulation: The PK population included all participants who received at least 1 dose of avacopan and had evaluable PK data.
AUC0-48 was obtained using noncompartmental analysis.
Outcome measures
| Measure |
Group 1: Normal Renal Function
n=6 Participants
Participants in Group 1 received a single dose of avacopan on Day 1.
|
Group 2; Period 1: ESRD Requiring HD (On-HD)
n=7 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 in treatment Period 1 while participants were on HD.
|
Group 2; Period 2: ESRD Requiring HD (Off-HD)
n=7 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 during treatment Period 2, when they were off HD.
|
|---|---|---|---|
|
AUC From Time Zero to 48 Hours (AUC0-48) of Avacopan
|
760 h*ng/mL
Geometric Coefficient of Variation 38.3
|
599 h*ng/mL
Geometric Coefficient of Variation 41.7
|
656 h*ng/mL
Geometric Coefficient of Variation 34.8
|
PRIMARY outcome
Timeframe: Group 1, Period 1: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36, and 48 hours postdose; Group 2, Periods 1 and 2: predose, 0.25,0.5,1,2,3,4,6,9,12,16,24,36, and 48 hours postdosePopulation: The PK population included all participants who received at least 1 dose of avacopan and had evaluable PK data.
AUC0-48 was obtained using noncompartmental analysis.
Outcome measures
| Measure |
Group 1: Normal Renal Function
n=6 Participants
Participants in Group 1 received a single dose of avacopan on Day 1.
|
Group 2; Period 1: ESRD Requiring HD (On-HD)
n=7 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 in treatment Period 1 while participants were on HD.
|
Group 2; Period 2: ESRD Requiring HD (Off-HD)
n=7 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 during treatment Period 2, when they were off HD.
|
|---|---|---|---|
|
AUC0-48 of Metabolite M1
|
349 h*ng/mL
Geometric Coefficient of Variation 17.6
|
236 h*ng/mL
Geometric Coefficient of Variation 19.1
|
230 h*ng/mL
Geometric Coefficient of Variation 23.9
|
PRIMARY outcome
Timeframe: Group 2, Period 1: 0.5, 1, 2 and 3 hours after start of HD and after end of HD at Day 1Population: The PK population included all participants who received at least 1 dose of avacopan and had evaluable PK data. CLD of avacopan was planned to be evaluated for Group 2, Period 1 only.
CLD determines how much of the drug is removed by hemodialysis.
Outcome measures
| Measure |
Group 1: Normal Renal Function
n=7 Participants
Participants in Group 1 received a single dose of avacopan on Day 1.
|
Group 2; Period 1: ESRD Requiring HD (On-HD)
Participants in Group 2 received a single dose of avacopan on Day 1 in treatment Period 1 while participants were on HD.
|
Group 2; Period 2: ESRD Requiring HD (Off-HD)
Participants in Group 2 received a single dose of avacopan on Day 1 during treatment Period 2, when they were off HD.
|
|---|---|---|---|
|
Dialysate Clearance (CLD) of Avacopan
|
NA liters per hour (L/h)
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variation were not calculable as no participants had quantifiable data for CLD of avacopan due to analytical limitations (below limit of quantification \[BLQ\]).
|
—
|
—
|
PRIMARY outcome
Timeframe: Group 2, Period 1: 0.5, 1, 2 and 3 hours after start of HD and after end of HD at Day 1Population: The PK population included all participants who received at least 1 dose of avacopan and had evaluable PK data. CLD of metabolite M1 was planned to be evaluated for Group 2, Period 1 only.
CLD determines how much of the drug is removed by hemodialysis.
Outcome measures
| Measure |
Group 1: Normal Renal Function
n=7 Participants
Participants in Group 1 received a single dose of avacopan on Day 1.
|
Group 2; Period 1: ESRD Requiring HD (On-HD)
Participants in Group 2 received a single dose of avacopan on Day 1 in treatment Period 1 while participants were on HD.
|
Group 2; Period 2: ESRD Requiring HD (Off-HD)
Participants in Group 2 received a single dose of avacopan on Day 1 during treatment Period 2, when they were off HD.
|
|---|---|---|---|
|
CLD of Metabolite M1
|
NA L/h
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variation were not calculable as no participants had quantifiable data for CLD of Metabolite M1 due to analytical limitations (BLQ).
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of study (EOS) (up to 36 days)Population: The safety population included all participants who received at least 1 dose of avacopan and had at least 1 post-dose safety assessment.
An adverse event was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) that was temporally associated with the use of a treatment, combination product, medical device, or procedure. A TEAEs was defined as an AE that started during or after first dose administration or started prior to first dose administration and increased in severity after dosing.
Outcome measures
| Measure |
Group 1: Normal Renal Function
n=6 Participants
Participants in Group 1 received a single dose of avacopan on Day 1.
|
Group 2; Period 1: ESRD Requiring HD (On-HD)
n=7 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 in treatment Period 1 while participants were on HD.
|
Group 2; Period 2: ESRD Requiring HD (Off-HD)
n=7 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 during treatment Period 2, when they were off HD.
|
|---|---|---|---|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
|
2 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From signing the informed consent form (ICF) to 30 days after EOS (up to 96 days)Population: The safety population included all participants who received at least 1 dose of avacopan and had at least 1 post-dose safety assessment.
A SAE was defined as any untoward medical occurrence that met at least 1 of the following criteria: results in death, is immediately life-threatening, required inpatient hospitalization or prolonged existing hospitalization, persistent or significant incapacity/disability, a congenital abnormality/birth defect, or other medically important serious event.
Outcome measures
| Measure |
Group 1: Normal Renal Function
n=6 Participants
Participants in Group 1 received a single dose of avacopan on Day 1.
|
Group 2; Period 1: ESRD Requiring HD (On-HD)
n=7 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 in treatment Period 1 while participants were on HD.
|
Group 2; Period 2: ESRD Requiring HD (Off-HD)
n=7 Participants
Participants in Group 2 received a single dose of avacopan on Day 1 during treatment Period 2, when they were off HD.
|
|---|---|---|---|
|
Number of Participants Who Experienced Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1: Normal Renal Function
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2; Period 1: ESRD Requiring HD (On-HD)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2; Period 2: ESRD Requiring HD (Off-HD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Normal Renal Function
n=6 participants at risk
Participants in Group 1 received a single dose of avacopan on Day 1.
|
Group 2; Period 1: ESRD Requiring HD (On-HD)
n=7 participants at risk
Participants in Group 2 received a single dose of avacopan on Day 1 in treatment Period 1 while participants were on HD.
|
Group 2; Period 2: ESRD Requiring HD (Off-HD)
n=7 participants at risk
Participants in Group 2 received a single dose of avacopan on Day 1 during treatment Period 2, when they were off HD.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • For TEAEs: from the first dose date through to the EOS; up to 36 days. For SAEs and all-cause mortality: from signing of ICF to 30 days after EOS; up to 96 days.
The safety population included all participants who received at least 1 dose of avacopan and had at least 1 post-dose safety assessment.
|
28.6%
2/7 • For TEAEs: from the first dose date through to the EOS; up to 36 days. For SAEs and all-cause mortality: from signing of ICF to 30 days after EOS; up to 96 days.
The safety population included all participants who received at least 1 dose of avacopan and had at least 1 post-dose safety assessment.
|
0.00%
0/7 • For TEAEs: from the first dose date through to the EOS; up to 36 days. For SAEs and all-cause mortality: from signing of ICF to 30 days after EOS; up to 96 days.
The safety population included all participants who received at least 1 dose of avacopan and had at least 1 post-dose safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • For TEAEs: from the first dose date through to the EOS; up to 36 days. For SAEs and all-cause mortality: from signing of ICF to 30 days after EOS; up to 96 days.
The safety population included all participants who received at least 1 dose of avacopan and had at least 1 post-dose safety assessment.
|
0.00%
0/7 • For TEAEs: from the first dose date through to the EOS; up to 36 days. For SAEs and all-cause mortality: from signing of ICF to 30 days after EOS; up to 96 days.
The safety population included all participants who received at least 1 dose of avacopan and had at least 1 post-dose safety assessment.
|
0.00%
0/7 • For TEAEs: from the first dose date through to the EOS; up to 36 days. For SAEs and all-cause mortality: from signing of ICF to 30 days after EOS; up to 96 days.
The safety population included all participants who received at least 1 dose of avacopan and had at least 1 post-dose safety assessment.
|
|
Infections and infestations
COVID-19
|
16.7%
1/6 • For TEAEs: from the first dose date through to the EOS; up to 36 days. For SAEs and all-cause mortality: from signing of ICF to 30 days after EOS; up to 96 days.
The safety population included all participants who received at least 1 dose of avacopan and had at least 1 post-dose safety assessment.
|
0.00%
0/7 • For TEAEs: from the first dose date through to the EOS; up to 36 days. For SAEs and all-cause mortality: from signing of ICF to 30 days after EOS; up to 96 days.
The safety population included all participants who received at least 1 dose of avacopan and had at least 1 post-dose safety assessment.
|
0.00%
0/7 • For TEAEs: from the first dose date through to the EOS; up to 36 days. For SAEs and all-cause mortality: from signing of ICF to 30 days after EOS; up to 96 days.
The safety population included all participants who received at least 1 dose of avacopan and had at least 1 post-dose safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER