An Open-Label, Multicenter, Extension Study to Evaluate the Long Term Safety of Intravenous CR845 in Hemodialysis Patients With Chronic Kidney Disease-Associated Pruritus
Phase: PHASE3
Conditions: Uremic Pruritus
Sponsor: Cara Therapeutics, Inc.

 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cara Therapeutics Inc. 
CR845-CLIN3101 
26 Apr2019 
Confidential 
Page 5 of58 
5.
Continues to experience chronic kidney disease-associated
pruritus since the previous study (ie, CR845-CLIN2005
[Part BJ or CR845-CLIN2101 [Part A]); de novo patients
experiencing chronic kidney disease-associated pruritus at the
time of Screening
6.
If female:
a.
Is not of childbearing potential (surgically sterile or
postmenopausal, as defined in Section 6.5.1.6); or
b.
Has a negative serum pregnancy test at screening and
agrees to use acceptable contraceptive measures ( as
defined in Section 6.5.1.6) from the time of informed
consent until the safety Follow-up Visit or 7 days after
the last dose of study drug, whichever is later.
7.
If male, agrees not to donate sperm after the first dose of study
drug until 7 days after the last dose, and agrees to use a
condom with spermicide or abstain from heterosexual
intercourse during the study until 7 days after study drug
administration. (Note: No restrictions are required for a
vasectomized male provided his vasectomy was performed
2:4 months prior to dosing);
8.
Has a dry body weight of 2:40.0 kg at screening (prescription
target dry body weight);
9.
Has adequacy of dialysis, defined as meeting 1 of the following
criteria during the 3 months prior to screening:
a.
2:2 single-pool Kt/V measurements 2: 1.2; or
b.
urea reduction ratio measurements 2:65%; or
c.
1 single-pool Kt/V measurement 2:1.2 and 1 urea
reduction ratio measurement 2:65%
10. For de novo patients only, has recorded up to 4 Worst Itching
Intensity NRS scores at dialysis visits over the week prior to
the first dose (including the score on Day 1 of dosing), and has
at least 1 of the NRS scores >4.
Amendment 1.2