Trial Outcomes & Findings for Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis (NCT NCT01478971)

NCT ID: NCT01478971

Last Updated: 2016-09-20

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

184 participants

Primary outcome timeframe

6 months

Results posted on

2016-09-20

Participant Flow

Participants took part in the study at 5 investigative sites in the United States from 11 October 2011 to 08 February 2013.

Participants with chronic kidney disease and on dialysis continued to receive their standard of care epoetin treatment for 6 months and then transitioned to receive peginesatide injection for 6 months.

Participant milestones

Participant milestones
Measure	Peginesatide Injection In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period \[SCP\]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period \[PTP\]).
Standard of Care Period STARTED	184
Standard of Care Period Received Treatment	178
Standard of Care Period COMPLETED	159
Standard of Care Period NOT COMPLETED	25
Peginesatide Treatment Period STARTED	157
Peginesatide Treatment Period COMPLETED	143
Peginesatide Treatment Period NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Peginesatide Injection In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period \[SCP\]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period \[PTP\]).
Standard of Care Period Adverse Event	1
Standard of Care Period Withdrawal by Subject	3
Standard of Care Period Death	8
Standard of Care Period Lost to Follow-up	9
Standard of Care Period Other	4
Peginesatide Treatment Period Adverse Event	1
Peginesatide Treatment Period Withdrawal by Subject	1
Peginesatide Treatment Period Death	4
Peginesatide Treatment Period Lost to Follow-up	4
Peginesatide Treatment Period Other	4

Baseline Characteristics

Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peginesatide Injection n=178 Participants In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period \[SCP\]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period \[PTP\]).
Age, Continuous	59.6 years STANDARD_DEVIATION 15.33 • n=5 Participants
Age, Customized < 65 years	103 participants n=5 Participants
Age, Customized 65 - 74 years	44 participants n=5 Participants
Age, Customized ≥ 75 years	31 participants n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	76 participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	102 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=5 Participants
Race/Ethnicity, Customized Asian	10 participants n=5 Participants
Race/Ethnicity, Customized Black	43 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	5 participants n=5 Participants
Race/Ethnicity, Customized White	119 participants n=5 Participants
Region of Enrollment United States	178 participants 3.71 • n=5 Participants
Weight	83.8 kg STANDARD_DEVIATION 22.93 • n=5 Participants
Time on dialysis	4.2 years STANDARD_DEVIATION 3.71 • n=5 Participants
Kidney transplant recipient Yes	17 participants n=5 Participants
Kidney transplant recipient No	161 participants n=5 Participants
Nephrotic syndrome history Yes	30 participants n=5 Participants
Nephrotic syndrome history No	148 participants n=5 Participants
Primary cause of chronic kidney disease Diabetes	97 participants n=5 Participants
Primary cause of chronic kidney disease Hypertension	37 participants n=5 Participants
Primary cause of chronic kidney disease Cystic renal disease	6 participants n=5 Participants
Primary cause of chronic kidney disease Interstitial nephritis	2 participants n=5 Participants
Primary cause of chronic kidney disease Glomerulonephritis	15 participants n=5 Participants
Primary cause of chronic kidney disease Urological	4 participants n=5 Participants
Primary cause of chronic kidney disease Immunoglobulin (Ig) A nephropathy	3 participants n=5 Participants
Primary cause of chronic kidney disease Congenital	1 participants n=5 Participants
Primary cause of chronic kidney disease Unknown	3 participants n=5 Participants
Primary cause of chronic kidney disease Other	10 participants n=5 Participants
Current dialysis frequency 2 times a week	3 participants n=5 Participants
Current dialysis frequency 3 times a week	169 participants n=5 Participants
Current dialysis frequency 4 times a week	4 participants n=5 Participants
Current dialysis frequency 5 times a week	1 participants n=5 Participants
Current dialysis frequency 6 times a week	1 participants n=5 Participants
Baseline hemoglobin	10.9 g/dL STANDARD_DEVIATION 0.96 • n=5 Participants
Ferritin	1068.7 ng/mL STANDARD_DEVIATION 513.1 • n=5 Participants
Transferrin saturation	35.2 percent saturation STANDARD_DEVIATION 13.85 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All participants who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Peginesatide Injection n=178 Participants In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period \[SCP\]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period \[PTP\]).	Peginesatide Treatment Period In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period \[PTP\]).
Percentage of Participants Undergoing Conversion to Peginesatide Injection	88 percentage of participants	—

SECONDARY outcome

Timeframe: Month 6 - 12

Population: Participants who received at least 1 dose of study treatment during the Peginesatide Treatment Period.

The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide.

Outcome measures

Outcome measures
Measure	Peginesatide Injection n=157 Participants In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period \[SCP\]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period \[PTP\]).	Peginesatide Treatment Period In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period \[PTP\]).
Peginesatide Dosing Starting Dose	5.1 mg Standard Deviation 2.82	—
Peginesatide Dosing Average Dose During Treatment Period	4.9 mg Standard Deviation 2.97	—
Peginesatide Dosing Last Weekly Average Dose	5.2 mg Standard Deviation 3.68	—

SECONDARY outcome

Timeframe: Months 6 - 12

Data collected by sponsor of study (Affymax), and sponsor did not provide aggregate summary data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Months 1, 2, 3, 4, 5 and 6 of each treatment period

Population: Full Analysis Population included all enrolled participants who received at least 1 dose of study treatment during the Peginesatide Treatment Period. n indicates the number of participants with available data at each time point.

Percentage of participants with hemoglobin values within the hemoglobin range of 10-11 g/dL.

Outcome measures

Outcome measures
Measure	Peginesatide Injection n=157 Participants In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period \[SCP\]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period \[PTP\]).	Peginesatide Treatment Period n=157 Participants In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period \[PTP\]).
Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL Month 5 (n=157, 147)	42.7 percentage of participants	44.9 percentage of participants
Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL Month 1 (n=156, 155)	39.1 percentage of participants	44.5 percentage of participants
Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL Month 2 (n=157, 155)	40.8 percentage of participants	46.5 percentage of participants
Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL Month 3 (n=156, 155)	41.0 percentage of participants	45.2 percentage of participants
Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL Month 4 (n=156, 151)	44.9 percentage of participants	49.0 percentage of participants
Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL Month6 (n=157, 146)	58.0 percentage of participants	39.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Safety population

Participants received iron supplementation during the study to prevent iron deficiency and to maintain iron stores.

Outcome measures

Outcome measures
Measure	Peginesatide Injection n=178 Participants In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period \[SCP\]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period \[PTP\]).	Peginesatide Treatment Period n=157 Participants In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period \[PTP\]).
Percentage of Participants Who Received at Least One Intravenous Iron Dose	85.4 percentage of participants	73.2 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Safety population

Outcome measures

Outcome measures
Measure	Peginesatide Injection n=178 Participants In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period \[SCP\]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period \[PTP\]).	Peginesatide Treatment Period n=157 Participants In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period \[PTP\]).
Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion	10.7 percentage of participants	8.3 percentage of participants

Adverse Events

Epoetin Standard of Care

Serious events: 64 serious events

Other events: 74 other events

Deaths: 0 deaths

ESA Free Week

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Peginesatide Treatment Period

Serious events: 54 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Epoetin Standard of Care n=178 participants at risk In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period \[SCP\]).	ESA Free Week n=160 participants at risk A one-week erythropoiesis-stimulating agent (ESA)-free period following 6 months of standard of care.	Peginesatide Treatment Period n=157 participants at risk In the second six months of the study participants transitioned to once monthly peginesatide injection (the Peginesatide Treatment Period \[PTP\]).
Blood and lymphatic system disorders Anaemia	7.3% 13/178 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/160 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.5% 4/157 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhoea	6.7% 12/178 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.62% 1/160 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.6% 12/157 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Vomiting	5.6% 10/178 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.2% 2/160 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.7% 9/157 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain upper	5.1% 9/178 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/160 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.9% 3/157 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	5.1% 9/178 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.62% 1/160 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 6/157 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Nasopharyngitis	5.1% 9/178 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.62% 1/160 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.5% 4/157 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Fall	5.6% 10/178 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/160 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.2% 16/157 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	8.4% 15/178 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.2% 2/160 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.4% 10/157 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperphosphataemia	3.9% 7/178 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.62% 1/160 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.1% 8/157 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	10.1% 18/178 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.62% 1/160 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.6% 15/157 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 10/178 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/160 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.5% 7/157 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	3.9% 7/178 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.62% 1/160 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 13/157 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dizziness	3.9% 7/178 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/160 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.0% 11/157 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Cough	6.7% 12/178 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/160 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.2% 5/157 • 12 months plus 4 to 5 weeks after the last dose of study treatment or last visit. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda

Phone: 800-778-2860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER