Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients

• Status: Completed
• Trial end date: 2019-09-14
• Target enrollment: 0
• Participant gender: All

Summary

Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaiser Permanente
• Collaborator: Keryx Biopharmaceuticals
• Treatments: Citric Acid; Ferric Compounds

Criteria

Inclusion Criteria:

• Currently using 3 to 18 pills per day of calcium acetate, sevelamer, lanthanum, or calcium carbonate

• Mean serum phosphorus 4.0-<8.0 mg/dl for 6 months prior to enrollment

• No allergy to iron

• Mean corrected serum calcium > 8.0 mg/dl for 6 months prior to enrollment

• Mean PTH < 1000 pg/ml for 6 months prior to enrollment

• Mean ferritin < 1500 ng/ml and mean iron sat < 50% for 6 months prior to enrollment

Exclusion Criteria:

• History of gastrointestinal bleeding within past 6 months

• History of hospitalization for gastroparesis, bowel obstruction, or abdominal surgery within past 6 months

• Acute kidney injury equal to or less than 3 months before the initial screening date

• Active malignancy

• Functioning renal transplant

• Patients with iron overload syndrome (e.g., Hemochromatosis)

• History autoimmune disease, hemoglobinopathy, hemochromatosis, sickle cell disease

• Active or past history of calciphylaxis