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Trial Outcomes & Findings for Evaluation of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis (NCT NCT02809183)

NCT ID: NCT02809183

Last Updated: 2020-01-14

Results Overview

The number and percentage of subjects who reported treatment-emergent adverse events (TEAEs) summarized by system organ class and preferred term (see Reported Adverse Events) as well as by severity, causality, seriousness, and action taken with regard to study drug. All analyses were descriptive.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

135 participants

Primary outcome timeframe

Through treatment period completion (Day 15)

Results posted on

2020-01-14

Participant Flow

Participant milestones

Participant milestones
Measure
Placebo BID
Placebo administered twice daily (BID) for 14 days
1.5g TRC101 BID
1.5g TRC101 administered twice daily (BID) for 14 days
3g TRC101 BID
3g TRC101 administered twice daily (BID) for 14 days
4.5g TRC101 BID
4.5g TRC101 administered twice daily (BID) for 14 days
Placebo QD
Placebo administered once daily (QD) for 14 days
6g TRC101 QD
6g TRC101 administered once daily (QD) for 14 days
Overall Study
STARTED
25
25
25
26
6
28
Overall Study
COMPLETED
25
25
25
26
6
28
Overall Study
NOT COMPLETED
0
0
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pooled Placebo
n=31 Participants
Pooled placebo treatment groups (Placebo administered twice daily \[BID\] for 14 days + Placebo administered once daily \[QD\] for 14 days)
1.5g TRC101 BID
n=25 Participants
1.5g TRC101 administered twice daily (BID) for 14 days
3g TRC101 BID
n=25 Participants
3g TRC101 administered twice daily (BID) for 14 days
4.5g TRC101 BID
n=26 Participants
4.5g TRC101 administered twice daily (BID) for 14 days
6g TRC101 QD
n=28 Participants
6g TRC101 administered once daily (QD) for 14 days
Total
n=135 Participants
Total of all reporting groups
Age, Continuous
61 years
STANDARD_DEVIATION 12 • n=99 Participants
58 years
STANDARD_DEVIATION 14 • n=107 Participants
60 years
STANDARD_DEVIATION 13 • n=206 Participants
61 years
STANDARD_DEVIATION 13 • n=157 Participants
63 years
STANDARD_DEVIATION 11 • n=390 Participants
60.3 years
STANDARD_DEVIATION 12.44 • n=16 Participants
Sex: Female, Male
Female
12 Participants
n=99 Participants
6 Participants
n=107 Participants
8 Participants
n=206 Participants
11 Participants
n=157 Participants
12 Participants
n=390 Participants
49 Participants
n=16 Participants
Sex: Female, Male
Male
19 Participants
n=99 Participants
19 Participants
n=107 Participants
17 Participants
n=206 Participants
15 Participants
n=157 Participants
16 Participants
n=390 Participants
86 Participants
n=16 Participants
Diabetes
20 Participants
n=99 Participants
18 Participants
n=107 Participants
20 Participants
n=206 Participants
19 Participants
n=157 Participants
17 Participants
n=390 Participants
94 Participants
n=16 Participants
Hypertension
30 Participants
n=99 Participants
24 Participants
n=107 Participants
23 Participants
n=206 Participants
23 Participants
n=157 Participants
26 Participants
n=390 Participants
126 Participants
n=16 Participants
Heart Failure
7 Participants
n=99 Participants
5 Participants
n=107 Participants
7 Participants
n=206 Participants
5 Participants
n=157 Participants
5 Participants
n=390 Participants
29 Participants
n=16 Participants
Serum Bicarbonate
17.6 mEq/L
STANDARD_DEVIATION 1.4 • n=99 Participants
18.0 mEq/L
STANDARD_DEVIATION 1.0 • n=107 Participants
17.8 mEq/L
STANDARD_DEVIATION 1.2 • n=206 Participants
17.5 mEq/L
STANDARD_DEVIATION 1.3 • n=157 Participants
17.7 mEq/L
STANDARD_DEVIATION 1.0 • n=390 Participants
17.72 mEq/L
STANDARD_DEVIATION 1.197 • n=16 Participants
eGFR
34 mL/min/1.73m^2
STANDARD_DEVIATION 14 • n=99 Participants
35 mL/min/1.73m^2
STANDARD_DEVIATION 13 • n=107 Participants
40 mL/min/1.73m^2
STANDARD_DEVIATION 13 • n=206 Participants
35 mL/min/1.73m^2
STANDARD_DEVIATION 13 • n=157 Participants
31 mL/min/1.73m^2
STANDARD_DEVIATION 10 • n=390 Participants
35.70 mL/min/1.73m^2
STANDARD_DEVIATION 12.419 • n=16 Participants

PRIMARY outcome

Timeframe: Through treatment period completion (Day 15)

Population: Safety Analysis Set

The number and percentage of subjects who reported treatment-emergent adverse events (TEAEs) summarized by system organ class and preferred term (see Reported Adverse Events) as well as by severity, causality, seriousness, and action taken with regard to study drug. All analyses were descriptive.

Outcome measures

Outcome measures
Measure
Pooled Placebo
n=31 Participants
Pooled placebo treatment groups (Placebo administered twice daily \[BID\] for 14 days + Placebo administered once daily \[QD\] for 14 days)
1.5g TRC101 BID
n=25 Participants
1.5g TRC101 administered twice daily (BID) for 14 days
3g TRC101 BID
n=25 Participants
3g TRC101 administered twice daily (BID) for 14 days
4.5g TRC101 BID
n=26 Participants
4.5g TRC101 administered twice daily (BID) for 14 days
6g TRC101 QD
n=28 Participants
6g TRC101 administered once daily (QD) for 14 days
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE
Subjects Reporting any TEAE
14 Participants
13 Participants
9 Participants
17 Participants
17 Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE
≥ 1 Mild TEAE
11 Participants
9 Participants
8 Participants
14 Participants
15 Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE
≥ 1 Moderate TEAE
3 Participants
4 Participants
1 Participants
3 Participants
2 Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE
≥ 1 Severe TEAE
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE
≥ 1 Serious TEAE
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE
Study Drug Discontinuation Due to TEAE
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Baseline and Day 15

Population: Full Analysis Set

Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline

Outcome measures

Outcome measures
Measure
Pooled Placebo
n=31 Participants
Pooled placebo treatment groups (Placebo administered twice daily \[BID\] for 14 days + Placebo administered once daily \[QD\] for 14 days)
1.5g TRC101 BID
n=25 Participants
1.5g TRC101 administered twice daily (BID) for 14 days
3g TRC101 BID
n=25 Participants
3g TRC101 administered twice daily (BID) for 14 days
4.5g TRC101 BID
n=26 Participants
4.5g TRC101 administered twice daily (BID) for 14 days
6g TRC101 QD
6g TRC101 administered once daily (QD) for 14 days
Change From Baseline to the End of Treatment (Day 15) in Serum Bicarbonate Within Each Individual TRC101 Dose Group
-0.2 mEq/L
Standard Error 0.4
3.2 mEq/L
Standard Error 0.4
3.0 mEq/L
Standard Error 0.4
3.7 mEq/L
Standard Error 0.4
—

SECONDARY outcome

Timeframe: Baseline and Day 15

Population: Full Analysis Set

Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for each TRC101 dose group versus that for Placebo

Outcome measures

Outcome measures
Measure
Pooled Placebo
n=31 Participants
Pooled placebo treatment groups (Placebo administered twice daily \[BID\] for 14 days + Placebo administered once daily \[QD\] for 14 days)
1.5g TRC101 BID
n=25 Participants
1.5g TRC101 administered twice daily (BID) for 14 days
3g TRC101 BID
n=25 Participants
3g TRC101 administered twice daily (BID) for 14 days
4.5g TRC101 BID
n=26 Participants
4.5g TRC101 administered twice daily (BID) for 14 days
6g TRC101 QD
6g TRC101 administered once daily (QD) for 14 days
Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between Each TRC101 Dose Group Versus Placebo
-0.2 mEq/L
Standard Error 0.4
3.2 mEq/L
Standard Error 0.4
3.0 mEq/L
Standard Error 0.4
3.7 mEq/L
Standard Error 0.4
—

SECONDARY outcome

Timeframe: Baseline and Day 15

Population: Full Analysis Set

Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline

Outcome measures

Outcome measures
Measure
Pooled Placebo
n=104 Participants
Pooled placebo treatment groups (Placebo administered twice daily \[BID\] for 14 days + Placebo administered once daily \[QD\] for 14 days)
1.5g TRC101 BID
1.5g TRC101 administered twice daily (BID) for 14 days
3g TRC101 BID
3g TRC101 administered twice daily (BID) for 14 days
4.5g TRC101 BID
4.5g TRC101 administered twice daily (BID) for 14 days
6g TRC101 QD
6g TRC101 administered once daily (QD) for 14 days
Change From Baseline in Serum Bicarbonate at Day 15 Within the Combined TRC101 Treatment Group
3.3 mEq/L
Standard Error 0.2
—
—
—
—

SECONDARY outcome

Timeframe: Baseline and Day 15

Population: Full Analysis Set

Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the Combined TRC101 Treatment Group versus that for Placebo

Outcome measures

Outcome measures
Measure
Pooled Placebo
n=31 Participants
Pooled placebo treatment groups (Placebo administered twice daily \[BID\] for 14 days + Placebo administered once daily \[QD\] for 14 days)
1.5g TRC101 BID
n=104 Participants
1.5g TRC101 administered twice daily (BID) for 14 days
3g TRC101 BID
3g TRC101 administered twice daily (BID) for 14 days
4.5g TRC101 BID
4.5g TRC101 administered twice daily (BID) for 14 days
6g TRC101 QD
6g TRC101 administered once daily (QD) for 14 days
Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between the Combined TRC101 Treatment Group Versus Placebo
-0.2 mEq/L
Standard Error 0.4
3.3 mEq/L
Standard Error 0.2
—
—
—

SECONDARY outcome

Timeframe: Baseline and Day 15

Population: Full Analysis Set

Comparison of the proportion of subjects whose serum bicarbonate values increased from Baseline to Day 15 by greater than or equal to 2, 3, or 4 mEq/L between each TRC101 BID Dose Group versus Placebo

Outcome measures

Outcome measures
Measure
Pooled Placebo
n=31 Participants
Pooled placebo treatment groups (Placebo administered twice daily \[BID\] for 14 days + Placebo administered once daily \[QD\] for 14 days)
1.5g TRC101 BID
n=25 Participants
1.5g TRC101 administered twice daily (BID) for 14 days
3g TRC101 BID
n=25 Participants
3g TRC101 administered twice daily (BID) for 14 days
4.5g TRC101 BID
n=26 Participants
4.5g TRC101 administered twice daily (BID) for 14 days
6g TRC101 QD
6g TRC101 administered once daily (QD) for 14 days
Comparison of the Proportion of Subjects Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Between Each TRC101 Dose Group Versus Placebo
=> 2 mEq/L Baseline Serum Bicarbonate
4 Participants
18 Participants
14 Participants
19 Participants
—
Comparison of the Proportion of Subjects Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Between Each TRC101 Dose Group Versus Placebo
=> 3 mEq/L Baseline Serum Bicarbonate
2 Participants
14 Participants
10 Participants
16 Participants
—
Comparison of the Proportion of Subjects Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Between Each TRC101 Dose Group Versus Placebo
=> 4 mEq/L Baseline Serum Bicarbonate
1 Participants
8 Participants
10 Participants
11 Participants
—

SECONDARY outcome

Timeframe: Baseline and Day 15

Population: Full Analysis Set

Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline

Outcome measures

Outcome measures
Measure
Pooled Placebo
n=28 Participants
Pooled placebo treatment groups (Placebo administered twice daily \[BID\] for 14 days + Placebo administered once daily \[QD\] for 14 days)
1.5g TRC101 BID
1.5g TRC101 administered twice daily (BID) for 14 days
3g TRC101 BID
3g TRC101 administered twice daily (BID) for 14 days
4.5g TRC101 BID
4.5g TRC101 administered twice daily (BID) for 14 days
6g TRC101 QD
6g TRC101 administered once daily (QD) for 14 days
Change From Baseline in Serum Bicarbonate at Day 15 Within the TRC101 6g QD Dose Group
3.5 mEq/L
Standard Error 0.4
—
—
—
—

SECONDARY outcome

Timeframe: Baseline and Day 15

Population: Full Analysis Set

Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the TRC101 6g dose group versus that for Placebo

Outcome measures

Outcome measures
Measure
Pooled Placebo
n=31 Participants
Pooled placebo treatment groups (Placebo administered twice daily \[BID\] for 14 days + Placebo administered once daily \[QD\] for 14 days)
1.5g TRC101 BID
n=28 Participants
1.5g TRC101 administered twice daily (BID) for 14 days
3g TRC101 BID
3g TRC101 administered twice daily (BID) for 14 days
4.5g TRC101 BID
4.5g TRC101 administered twice daily (BID) for 14 days
6g TRC101 QD
6g TRC101 administered once daily (QD) for 14 days
Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus Placebo
-0.2 mEq/L
Standard Error 0.4
3.5 mEq/L
Standard Error 0.4
—
—
—

SECONDARY outcome

Timeframe: Baseline and Day 15

Population: Full Analysis Set

Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the TRC101 6g QD dose group versus that for the TRC101 3g BID dose group

Outcome measures

Outcome measures
Measure
Pooled Placebo
n=25 Participants
Pooled placebo treatment groups (Placebo administered twice daily \[BID\] for 14 days + Placebo administered once daily \[QD\] for 14 days)
1.5g TRC101 BID
n=28 Participants
1.5g TRC101 administered twice daily (BID) for 14 days
3g TRC101 BID
3g TRC101 administered twice daily (BID) for 14 days
4.5g TRC101 BID
4.5g TRC101 administered twice daily (BID) for 14 days
6g TRC101 QD
6g TRC101 administered once daily (QD) for 14 days
Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus the TRC101 3g BID Dose Group
3.0 mEq/L
Standard Error 0.4
3.5 mEq/L
Standard Error 0.4
—
—
—

SECONDARY outcome

Timeframe: Baseline and Day 15

Population: Full Analysis Set

Comparison of the proportion of subjects whose serum bicarbonate values increased from Baseline to Day 15 by greater than or equal to 2, 3, or 4 mEq/L between the 6g TRC101 QD Dose Group versus Placebo

Outcome measures

Outcome measures
Measure
Pooled Placebo
n=31 Participants
Pooled placebo treatment groups (Placebo administered twice daily \[BID\] for 14 days + Placebo administered once daily \[QD\] for 14 days)
1.5g TRC101 BID
n=28 Participants
1.5g TRC101 administered twice daily (BID) for 14 days
3g TRC101 BID
3g TRC101 administered twice daily (BID) for 14 days
4.5g TRC101 BID
4.5g TRC101 administered twice daily (BID) for 14 days
6g TRC101 QD
6g TRC101 administered once daily (QD) for 14 days
Comparison of the Proportion of Subjects in the TRC101 6g QD Dose Group Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Versus Placebo
=> 4 mEq/L Baseline Serum Bicarbonate
1 Participants
12 Participants
—
—
—
Comparison of the Proportion of Subjects in the TRC101 6g QD Dose Group Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Versus Placebo
=> 2 mEq/L Baseline Serum Bicarbonate
4 Participants
23 Participants
—
—
—
Comparison of the Proportion of Subjects in the TRC101 6g QD Dose Group Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Versus Placebo
=> 3 mEq/L Baseline Serum Bicarbonate
2 Participants
14 Participants
—
—
—

Adverse Events

Pooled Placebo

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

1.5g TRC101 BID

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

3g TRC101 BID

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

4.5g TRC101 BID

Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths

6g TRC101 QD

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Pooled Placebo
n=31 participants at risk
Pooled Placebo treatment group (Placebo administered twice daily \[BID\] for 14 days + Placebo administered once daily \[QD\] for 14 days)
1.5g TRC101 BID
n=25 participants at risk
1.5g TRC101 administered twice daily (BID) for 14 days
3g TRC101 BID
n=25 participants at risk
3g TRC101 administered twice daily (BID) for 14 days
4.5g TRC101 BID
n=26 participants at risk
4.5g TRC101 administered twice daily (BID) for 14 days
6g TRC101 QD
n=28 participants at risk
6g TRC101 administered once daily (QD) for 14 days
Gastrointestinal disorders
Diarrhoea
12.9%
4/31 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
36.0%
9/25 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
12.0%
3/25 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
23.1%
6/26 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
10.7%
3/28 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
Gastrointestinal disorders
Constipation
0.00%
0/31 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
4.0%
1/25 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
4.0%
1/25 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
7.7%
2/26 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
10.7%
3/28 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
Investigations
Glomerular filtration rate decreased
6.5%
2/31 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
8.0%
2/25 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
4.0%
1/25 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
3.8%
1/26 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
0.00%
0/28 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
Investigations
Blood glucose increased
6.5%
2/31 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
4.0%
1/25 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
0.00%
0/25 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
0.00%
0/26 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
3.6%
1/28 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/31 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
0.00%
0/25 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
8.0%
2/25 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
7.7%
2/26 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
10.7%
3/28 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
Metabolism and nutrition disorders
Hypoglycaemia
6.5%
2/31 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
8.0%
2/25 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
4.0%
1/25 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
7.7%
2/26 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
0.00%
0/28 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
Nervous system disorders
Headache
3.2%
1/31 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
16.0%
4/25 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
4.0%
1/25 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
7.7%
2/26 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
3.6%
1/28 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
Vascular disorders
Hypertension
3.2%
1/31 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
4.0%
1/25 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
0.00%
0/25 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
7.7%
2/26 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.
7.1%
2/28 • Through treatment period completion (Day 15)
All subjects completed dosing per protocol and are included in the safety results.

Additional Information

Medical Information

Tricida, Inc.

Phone: 415-429-7800

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place