Renal InsufficiencyPhase 1NCT01432535

Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)

A Phase 1 study testing PegIFN-2b (Sylatron®) in people with Renal Insufficiency, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b (Sylatron®) in healthy participants to that in participants with moderate to severe impairment of kidney function. Read more about this study

Who is it for?: Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Renal Insufficiency
What is being tested?: PegIFN-2b (Sylatron®)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: No sites listed yet
Study dates: Nov 2011to Aug 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Body Mass Index (BMI) between 19 to 40 kg/m^2, inclusive
Moderate renal impairment and severe renal impairment and/or end-stage renal disease (ESRD) who may require hemodialysis and normal renal function
Free of any clinically significant disease (except those related to renal disease and comorbid conditions) that requires a physician's care and would interfere with the study
Females of reproductive potential must have used a medically accepted method of contraception for three months prior to screening and must agree to use an accepted contraceptive method during and for two months following the study
Males must agree to use a medically accepted method of contraception during the trial and for 3 months after the study

Who cannot join

Pregnant, intend to become pregnant, or breastfeeding
Surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
History of any infectious disease within 4 weeks prior to study drug administration that affects ability to participate in the study
Positive for hepatitis B surface antigen, and/or for human immunodeficiency virus (HIV) antibodies. Healthy participants positive for hepatitis C antibodies
Previously received PegIntron®, Sylatron®, and/or Pegasys
More than 10 cigarettes or equivalent tobacco use per day

Show all 13Show fewer

History of malignancy
Hypothyroidism or hyperthyroidism
History of depression requiring treatment with psychotherapy or medication
History of suicidality or at risk of self-harm or harm to others
History of autoimmune disorder requiring medical therapy
Immune mediated renal insufficiency
Removal of a kidney (healthy participants) or functioning renal transplant (participants with renal impairment)

About this study

Official title: A Single Dose Study to Assess Pharmacokinetics of SCH 54031 in Patients With Renal Impairment (P05655)

Conditions: Renal Insufficiency
Being tested: PegIFN-2b (Sylatron®)
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PegIFN-2b (Sylatron®)Drug
Also called PegIntron®, Peginterferon alfa-2b, SCH 054031, MK-4031
Single 4.5 μg/kg dose

Study groups in NCT01432535
Study group	Role	What they receive
Healthy Participants	Active comparator	Participants with normal renal function defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. Receives: Drug: PegIFN-2b (Sylatron®)
Participants with Moderate Renal Impairment	Experimental	Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. Receives: Drug: PegIFN-2b (Sylatron®)
Participants with Severe Renal Impairment	Experimental	Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. Receives: Drug: PegIFN-2b (Sylatron®)

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.
Measured: From hour 0 (pre-dose) to 288 hours post-dose
AUC From Time 0 to the Last Measurable Sample (AUC0-last)
AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample.
Measured: From hour 0 (pre-dose) up to 288 hours post-dose
Maximum Observed Serum Concentration (Cmax)
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
Measured: From hour 0 (pre-dose) to 288 hours post-dose
Time to Maximum Observed Serum Concentration (Tmax)
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.
Measured: From hour 0 (pre-dose) up to 288 hours post-dose
Apparent Terminal Half-life (T1/2)
T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.
Measured: From hour 0 (pre-dose) up to 288 hours post-dose
Apparent Total Body Clearance (CL/F)
CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).
Measured: From hour 0 (pre-dose) up to 288 hours post-dose
Apparent Volume of Distribution (Vd/F)
Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.
Measured: From hour 0 (pre-dose) up to 288 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Aug 2012

First posted13 Sep 2011 (estimated)
Study startNov 2011
Primary completionAug 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01432535
Sponsor's protocol ID: P05655
Other IDs: MK-4031-350
Status last verified: Mar 2017
First submitted: 9 Sep 2011
Last updated: 7 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
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NightWare and Cardiovascular Health in Women With PTSD
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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All Renal Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose Study to Assess Pharmacokinetics of SCH 54031 in Patients With Renal Impairment (P05655)
ClinicalTrials.gov ID: NCT01432535
Acronym / sponsor ID: P05655
Conditions: Renal Insufficiency
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 13 Sep 2011 (estimated)
Results: Posted 25 Sep 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Healthy Participants	Active comparator	Drug: PegIFN-2b (Sylatron®)Participants with normal renal function defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
Participants with Moderate Renal Impairment	Experimental	Drug: PegIFN-2b (Sylatron®)Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
Participants with Severe Renal Impairment	Experimental	Drug: PegIFN-2b (Sylatron®)Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Body Mass Index (BMI) between 19 to 40 kg/m^2, inclusive
Moderate renal impairment and severe renal impairment and/or end-stage renal disease (ESRD) who may require hemodialysis and normal renal function
Free of any clinically significant disease (except those related to renal disease and comorbid conditions) that requires a physician's care and would interfere with the study
Females of reproductive potential must have used a medically accepted method of contraception for three months prior to screening and must agree to use an accepted contraceptive method during and for two months following the study
Males must agree to use a medically accepted method of contraception during the trial and for 3 months after the study

Key exclusion criteria (13 listed)

Pregnant, intend to become pregnant, or breastfeeding
Surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
History of any infectious disease within 4 weeks prior to study drug administration that affects ability to participate in the study
Positive for hepatitis B surface antigen, and/or for human immunodeficiency virus (HIV) antibodies. Healthy participants positive for hepatitis C antibodies
Previously received PegIntron®, Sylatron®, and/or Pegasys

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PegIFN-2b (Sylatron®)Also: PegIntron®, Peginterferon alfa-2b, SCH 054031, MK-4031Single 4.5 μg/kg dose	Drug	Healthy Participants, Participants with Moderate Renal Impairment, Participants with Severe Renal Impairment

Primary outcome

Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
Time frame: From hour 0 (pre-dose) to 288 hours post-dose
AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.
AUC From Time 0 to the Last Measurable Sample (AUC0-last)
Time frame: From hour 0 (pre-dose) up to 288 hours post-dose
AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample.
Maximum Observed Serum Concentration (Cmax)
Time frame: From hour 0 (pre-dose) to 288 hours post-dose
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
Time to Maximum Observed Serum Concentration (Tmax)
Time frame: From hour 0 (pre-dose) up to 288 hours post-dose
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.
Apparent Terminal Half-life (T1/2)
Time frame: From hour 0 (pre-dose) up to 288 hours post-dose
T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.
Apparent Total Body Clearance (CL/F)
Time frame: From hour 0 (pre-dose) up to 288 hours post-dose
CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).
Apparent Volume of Distribution (Vd/F)
Time frame: From hour 0 (pre-dose) up to 288 hours post-dose
Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.

Results and safety

Results posted to the registry on 25 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Participants	12	12
Participants With Moderate Renal Impairment	7	7
Participants With Severe Renal Impairment	6	6

Primary outcome: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)

Time frame: From hour 0 (pre-dose) to 288 hours post-dose. Least squares mean (95% Confidence Interval). Unit: pg*hr/mL

Measure	Healthy Participants n = 12	Participants With Moderate Renal Impairment n = 6	Participants With Severe Renal Impairment n = 6
Value	305315.22 (175840.19 to 530125.58)	435500.38 (248562.28 to 763030.40)	658413.69 (395164.74 to 10907032.58)

Population analysed: All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.

Primary outcome: AUC From Time 0 to the Last Measurable Sample (AUC0-last)

Time frame: From hour 0 (pre-dose) up to 288 hours post-dose. Least squares mean (95% Confidence Interval). Unit: pg*hr/mL

Measure	Healthy Participants n = 12	Participants With Moderate Renal Impairment n = 6	Participants With Severe Renal Impairment n = 6
Value	286946.43 (164687.09 to 499967.87)	408889.84 (232550.52 to 718944.43)	598863.88 (358269.15 to 1001029.37)

Population analysed: All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.

Primary outcome: Maximum Observed Serum Concentration (Cmax)

Time frame: From hour 0 (pre-dose) to 288 hours post-dose. Geometric mean (95% Confidence Interval). Unit: pg/mL

Measure	Healthy Participants n = 12	Participants With Moderate Renal Impairment n = 6	Participants With Severe Renal Impairment n = 6
Value	2547.85 (1115.61 to 5818.84)	3210.16 (1386.73 to 7431.24)	3551.03 (1653.85 to 7624.49)

Population analysed: All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.

Primary outcome: Time to Maximum Observed Serum Concentration (Tmax)

Time frame: From hour 0 (pre-dose) up to 288 hours post-dose. Median (95% Confidence Interval). Unit: hours

Measure	Healthy Participants n = 12	Participants With Moderate Renal Impairment n = 6	Participants With Severe Renal Impairment n = 6
Value	12.0 (9.0 to 72.0)	12.0 (12.0 to 72.0)	60.0 (24.0 to 96.3)

Population analysed: All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Participants	0 of 12 (0%)	12 of 12 (100%)	Not reported
Participants With Moderate Renal Impairment	0 of 7 (0%)	7 of 7 (100%)	Not reported
Participants With Severe Renal Impairment	1 of 6 (16.7%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Renal Insufficiency

Active, not recruitingPhase 2
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End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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RecruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PegIFN-2b (Sylatron®) in people with Renal Insufficiency, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) (time frame: From hour 0 (pre-dose) to 288 hours post-dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01432535.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.