A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients

• Sponsor: Rockwell Medical Technologies, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04042324
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 3
• Actual Duration (Months): 3.5
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

This study will investigate the effect of co-administration of Triferic and heparin on the ability to maintain circuit anti-coagulation and iron delivery when compared to control conditions when each treatment is administered via separate routes.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease	Drug: Triferic; Drug: Heparin	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized 3 Period Crossover Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
• Actual Study Start Date: Sep 30, 2019
• Actual Primary Completion Date: Jan 16, 2020
• Actual Study Completion Date: Jan 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Triferic post-dialyzer; UFH via continuous infusion Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis.	Drug: Triferic; Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.; Other Names: ferric pyrophosphate citrate FPC ; Drug: Heparin; Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.; Other Names: Unfractionated heparin UFH
Experimental: UFH and Triferic admixture Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis.	Drug: Triferic; Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.; Other Names: ferric pyrophosphate citrate FPC ; Drug: Heparin; Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.; Other Names: Unfractionated heparin UFH
Experimental: UFH via continuous infusion pre-dialyzer Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis	Drug: Heparin; Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.; Other Names: Unfractionated heparin UFH

Outcome Measures

Primary Outcome Measures

1. Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t [8 hours]

Secondary Outcome Measures

1. Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours [4 hours]

2. aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours [4 hours]

3. TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours [4 hours]

4. Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration) [8 hours]

5. Iron Profile as Measured by the AUC (Area Under the Curve) 0-t [8 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Adult hemodialysis patients ≥18 years of age.

2. Signed informed consent to participate in the study.

3. Stable on hemodialysis prescription for ≥3 months.

4. Hemoglobin concentration >9.5 g/dL.

5. Serum TSAT ≥20%.

6. Able to receive continuous heparin infusion as their anticoagulation protocol.

7. Receiving hemodialysis via AV (arteriovenous) fistula or graft.

8. Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.

Exclusion Criteria:

1. Active bleeding disorder (GI, skin, nasal…)

2. Receiving hemodialysis via catheter.

3. Receiving heparin free dialysis.

4. Receiving low molecular weight heparin as sole anti-coagulation for dialysis.

5. Receiving IV iron within 2 weeks of the first on-study hemodialysis treatment.

6. Receiving oral anti-coagulants or anti-platelet agents.

7. Any other condition, that in the opinion of the investigator would not allow completion of the 3 hemodialysis treatments in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orlando Clinical Research Center	Orlando	Florida	United States	32809

Sponsors and Collaborators

• Rockwell Medical Technologies, Inc.

Investigators

• Study Director: Raymond Pratt, MD, Rockwell Medical

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 12, 2019

More Information

Publications

None provided.

• Responsible Party: Rockwell Medical Technologies, Inc.
• ClinicalTrials.gov Identifier: NCT04042324
• Other Study ID Numbers: RMFPC-24
• First Posted: Aug 1, 2019
• Last Update Posted: Dec 2, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Failure, Chronic; Heparin; Calcium heparin

Study Results

Participant Flow

Pre-assignment Detail	All twelve participants enrolled in the study were randomly assigned to cross-over between the three treatments on Days 1, 3 and 5.

Arm/Group Title	UFH and Triferic Admixture (Day 1)	Triferic Post-dialyzer; UFH Via Continuous Infusion (Day 3)	UFH Via Continuous Infusion Pre-dialyzer (Day 5)
Arm/Group Description	Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis.	Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis.	Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis
Period Title: UFH and Triferic Admixture (Day 1)
STARTED	12	0	0
COMPLETED	12	0	0
NOT COMPLETED	0	0	0
Period Title: UFH and Triferic Admixture (Day 1)
STARTED	0	12	0
COMPLETED	0	12	0
NOT COMPLETED	0	0	0
Period Title: UFH and Triferic Admixture (Day 1)
STARTED	0	0	12
COMPLETED	0	0	12
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Safety Population
Arm/Group Description	All patients enrolled in the study.
Overall Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.0 (9.8)
Sex: Female, Male (Count of Participants)
Female	3 25%
Male	9 75%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	12 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	11 91.7%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	1 8.3%

Outcome Measures

1. Primary Outcome

Title	Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UFH and Triferic Admixture	UFH Via Continuous Infusion Pre-dialyzer
Arm/Group Description	Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Measure Participants	12	12
Geometric Mean (Geometric Coefficient of Variation) [IU*hr/mL]	.798 (61.6)	.733 (62.4)

2. Secondary Outcome

Title	Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours
Time Frame	4 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Triferic Post-dialyzer; UFH Via Continuous Infusion	UFH and Triferic Admixture	UFH Via Continuous Infusion Pre-dialyzer
Arm/Group Description	Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Measure Participants	12	12	12
Geometric Mean (Geometric Coefficient of Variation) [IU*hr/mL]	.581 (75.7)	.600 (77.9)	.538 (81.0)

3. Secondary Outcome

Title	aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
Time Frame	4 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Triferic Post-dialyzer; UFH Via Continuous Infusion	UFH and Triferic Admixture	UFH Via Continuous Infusion Pre-dialyzer
Arm/Group Description	Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Measure Participants	12	12	12
Geometric Mean (Geometric Coefficient of Variation) [IU*hr/mL]	188 (37.7)	196 (38.5)	188 (39.8)

4. Secondary Outcome

Title	TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
Time Frame	4 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Triferic Post-dialyzer; UFH Via Continuous Infusion	UFH and Triferic Admixture	UFH Via Continuous Infusion Pre-dialyzer
Arm/Group Description	Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Measure Participants	12	12	12
Geometric Mean (Geometric Coefficient of Variation) [IU*hr/mL]	97.6 (31.6)	98.0 (34.6)	104 (40.1)

5. Secondary Outcome

Title	Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration)
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Triferic Post-dialyzer; UFH Via Continuous Infusion	UFH and Triferic Admixture
Arm/Group Description	Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Measure Participants	12	12
Geometric Mean (Geometric Coefficient of Variation) [ug/dL]	180 (20.9)	174 (31.5)

6. Secondary Outcome

Title	Iron Profile as Measured by the AUC (Area Under the Curve) 0-t
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Triferic Post-dialyzer; UFH Via Continuous Infusion	UFH and Triferic Admixture
Arm/Group Description	Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Measure Participants	12	12
Geometric Mean (Geometric Coefficient of Variation) [h*ug/dL]	1040 (31.1)	1050 (43.4)

Adverse Events

Time Frame	1.5 weeks
Adverse Event Reporting Description	Adverse events were collected from date of enrollment through the date of final study visit.
Arm/Group Title	Triferic Post-dialyzer; UFH Via Continuous Infusion		UFH and Triferic Admixture		UFH Via Continuous Infusion Pre-dialyzer
Arm/Group Description	Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.		Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. Triferic: Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate. Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.		Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
All Cause Mortality
	Triferic Post-dialyzer; UFH Via Continuous Infusion		UFH and Triferic Admixture		UFH Via Continuous Infusion Pre-dialyzer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/12 (0%)
Serious Adverse Events
	Triferic Post-dialyzer; UFH Via Continuous Infusion		UFH and Triferic Admixture		UFH Via Continuous Infusion Pre-dialyzer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Triferic Post-dialyzer; UFH Via Continuous Infusion		UFH and Triferic Admixture		UFH Via Continuous Infusion Pre-dialyzer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.