Relypsa

Relypsa Clinical Research Study


To apply for this study or to find out more information, come into our main office or contact:

      Melissa Bartel  
  Research Coordinator
     (210) 445-0798
        Main Office
     315 N San Saba
San Antonio, TX, 78207

Reward: $35.00/ visit
Duration: 6 weeks
Description: The Effect of Food: An open-label, randomized, parallel group phase 4 study of the efficiency and safety of Patiromer for oral suspension with or without food for the treatment of Hyperkalemia (TOURMALINE).
Each patient should meet all of the inclusion and exclusion criteria for this study. Under no circumstances can there be exceptions to this rule.

Inclusion Criteria
By meeting these, you can qualify for the study
  1. Provide written informed consent prior to participation in the study.
  2. Greater than 18 years of age.
  3. Potassium: two local K+ values of >5.0 mEq/L each obtained from a separate venipuncture (e.g. one in each arm) at Screening.
  4. If taking any RAASi, beta blockers or diuretic medications, must be on stable dose for at least 14 days prior to the Screening.
  5. Any concomitant medication being taken on a consistent basis must either be a QD or BID dosing regimen.
  6. Females of child-bearing potential must be non-locating, must have a negative pregnancy test at Screening, and must have use a highly effective form of contraception (e.g. hormonal, chemical, physical barrier, etc.) for at least 3 months before patiromer administration.
  7. Female subjects of child-bearing potential; must agree to continue using contraception throughout the study and for 1 month after the last dose of patiromer.

Exclusion Criteria
By meeting these, you cannot qualify for the study
  1. Subjects receiving dialysis or expected to need dialysis during this study Treatment Period.
  2. Subjects with a history of abnormally high numbers of platelets (>500,000/mm3), leukocytes (> 70,000/mm3), or erythrocytes (hematocrit > 55%).
  3. Heart, liver, or kidney transplants recipient, or anticipated need for transplant during the study Treatment Period
  4. A history of or current diagnosis of a severe swallowing disorder, moderate to severe gastroparesis, or history of bariatric surgery, bowel obstruction or sever gastrointestinal disorders or major gastrointestinal surgery (e.g. bowel resection)
  5. History of alcoholism or drug/chemical abuse within 1 year of Screening
  6. Subjects currently being treated with or having taken any one of the following medications (includes resins) in the 7 days prior to Screening: calcium or potassium supplementation (acetate, carbonate, gluconate or other formulations), sodium or calcium polystyrene sulfonate, drospirenone, trimethoprim, cotrimoxazole, tacrolimus, mycophenolate mofetil, or cyclosporine.
  7. Use of the following medications if doses have not been stable for at least 14 days prior to the Screening or if doses are anticipated to change during study participation:
a. digoxin
b. bronchodilators
c. theophylline
d. heparins (including low molecular heparins)
e. canagliflozin (or other glycosuric agent)
     8. Use of any investigational product for an unapproved indication within 30 days prior to Screening or   within 5 half-lives, whichever is longer.
     9. Known hypersensitivity to patiromer or its components.
    10. Inability to consume the investigational product or, in the opinion of the investigator, inability to comply with the protocol.
     11. In the opinion of the Investigator, any medical condition, uncontrolled systemic disease, or serious inter-current illness that would significantly decrease study compliance or jeopardize the safety of the subject or potentially affect the quality of the data such as: hyperkalemia at Screening that requires that requires emergency intervention , cardiovascular event, or intervention within 3 months prior to Screening, a hemodynamically unstable arrhythmia, hospitalization for HF within the past 3 months; poorly controlled blood pressures (BP); poorly controlled diabetes mellitus or frequent need for adjustment in insulin prescription or recent hospitalization for treatment of hyper or hypoglycemia.
   12. Active cancer, currently on cancer treatment or history of cancer in the past 2 years (except for        non-melanoma skin cancer).

 

 

Top