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A Study of MK-7145 in Participants With Renal Insufficiency (Part I) and Heart Failure With Renal Insufficiency (Part II) (MK-7145-011)

This study has been terminated.
(Lack of efficacy)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01558674
First Posted: March 20, 2012
Last Update Posted: April 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: January 11, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Renal Impairment
Heart Failure
Interventions: Drug: MK-7145
Drug: Furosemide
Drug: Torsemide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study was terminated early due to lack of efficacy of MK-7145. Only 11 participants were enrolled and dosed in Part 1. Period 3 of Part 1 was not conducted. No participants were enrolled in the planned Part 2 of the study.

Reporting Groups
  Description
MK-7145 8 mg→Furosemide 40 mg 2 x Day (BID)→ MK-7145 16 mg Part 1: Participants receive 8 mg MK-7145 once daily (QD) for 5 days, then furosemide 40 mg BID for 5 days and then 16 mg MK-7145 QD for 5 days. Each treatment period was separated by a 3-day wash-out.
Furosemide/Torsemide→MK-7145 10 mg→MK-7145 16 mg→MK-7145 24 mg Part 2: Participants receive Furosemide/Torsemide for 2 weeks , then 10 mg MK-7145 for 14 days, then MK-7145 16 mg for 14 days and then MK-7145 24 mg for 28 days. Each treatment period was separated by a 3-day wash-out.

Participant Flow for 2 periods

Period 1:   Part 1
    MK-7145 8 mg→Furosemide 40 mg 2 x Day (BID)→ MK-7145 16 mg   Furosemide/Torsemide→MK-7145 10 mg→MK-7145 16 mg→MK-7145 24 mg
STARTED   11   0 
COMPLETED   0   0 
NOT COMPLETED   11   0 
Study Terminated by Sponsor                10                0 
Withdrawal by Subject                1                0 

Period 2:   Part 2
    MK-7145 8 mg→Furosemide 40 mg 2 x Day (BID)→ MK-7145 16 mg   Furosemide/Torsemide→MK-7145 10 mg→MK-7145 16 mg→MK-7145 24 mg
STARTED   0   0 
COMPLETED   0   0 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MK-7145 8 mg→Furosemide 40 mg 2 x Day (BID)→ MK-7145 16 mg Part 1: Participants receive 8 mg MK-7145 once daily (QD) for 5 days, then furosemide 40 mg BID for 5 days and then 16 mg MK-7145 QD for 5 days. Each treatment period was separated by a 3-day wash-out.
Furosemide/Torsemide→MK-7145 10 mg→MK-7145 16 mg→MK-7145 24 mg Part 2: Participants receive Furosemide/Torsemide for 2 weeks , then 10 mg MK-7145 for 14 days, then MK-7145 16 mg for 14 days and then MK-7145 24 mg for 28 days. Each treatment period was separated by a 3-day wash-out.
Total Total of all reporting groups

Baseline Measures
   MK-7145 8 mg→Furosemide 40 mg 2 x Day (BID)→ MK-7145 16 mg   Furosemide/Torsemide→MK-7145 10 mg→MK-7145 16 mg→MK-7145 24 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   0   11 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.4  (16.0)      61.4  (16.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  27.3%         3  27.3% 
Male      8  72.7%         8  72.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in First 24hr Urinary Sodium (UNa) (Part 1)   [ Time Frame: Baseline (Day -1) and 0-24 hours postdose on Treatment Day 1 of each treatment period ]

2.  Primary:   N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) Values at 24 Hours Post Last Morning Dose of Each Period (Part 2)   [ Time Frame: Day 15 for Periods 1, 2, and 3; Day 29 for Period 4 ]

3.  Secondary:   Fold Change From Baseline for Serum Creatinine at 24-hours Post Treatment Day 5 Morning Dose (Part 1)   [ Time Frame: Baseline (predose Treatment Day 1) and 24 hours post morning dose on Treatment Day 5 of each treatment period (Part I) ]

4.  Secondary:   Area Under the Concentration-time Curve From Time Zero to 24 Hours After Dosing (AUC0-24hr) of MK-7145 (Treatment Days 1 and 5: Part 1)   [ Time Frame: up to 24 hours post-dose on Treatment Day 1 and Treatment Day 5 ]

5.  Secondary:   Maximum Plasma Concentration (Cmax) of MK-7145 (Treatment Days 1 and 5: Part 1)   [ Time Frame: Treatment Day 1 and Treatment Day 5 ]

6.  Secondary:   Trough Plasma Concentration (Ctrough) of MK-7145 (Treatment Days 1 and 5: Part 1)   [ Time Frame: Treatment Day 1 and Treatment Day 5 ]

7.  Secondary:   Time to Cmax (Tmax) of MK-7145(Treatment Days 1 and 5: Part 1)   [ Time Frame: Treatment Day 1 and Treatment Day 5 ]

8.  Secondary:   Apparent Terminal Half-life (t1/2) of MK-7145 (Part 1)   [ Time Frame: Treatment Day 1 and Treatment Day 5 ]

9.  Secondary:   Serum Creatinine Measured at 24 Hours Post Last Morning Dose of Each Period (Part 2)   [ Time Frame: Day 15 for Periods 1, 2, and 3; Day 29 for Period 4 ]

10.  Secondary:   Area Under the Concentration-time Curve From Time Zero to 24 Hours After Dosing (AUC0-24hr) of MK-7145 (Part 2)   [ Time Frame: up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 ]

11.  Secondary:   Maximum Plasma Concentration (Cmax) of MK-7145 (Part 2)   [ Time Frame: up to 24 hours post morning dose on up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 ]

12.  Secondary:   Trough Plasma Concentration (Ctrough) of MK-7145 (Part 2)   [ Time Frame: up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 ]

13.  Secondary:   Time to Cmax (Tmax) of MK-7145(Part 2)   [ Time Frame: up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 ]

14.  Secondary:   Apparent Terminal Half-life (t1/2) of MK-7145 (Part 2)   [ Time Frame: up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study terminated early due to lack of efficacy.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked 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.
unchecked 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01558674     History of Changes
Other Study ID Numbers: 7145-011
First Submitted: March 16, 2012
First Posted: March 20, 2012
Results First Submitted: January 11, 2017
Results First Posted: April 27, 2017
Last Update Posted: April 27, 2017