Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
Completed · Phase 2
Conditions studied: Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure
In brief
This study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK) in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis. This study will also investigate the safety and effects of different strengths of CTA018, on parathyroid hormone (PTH) levels.
Key facts
- Study ID
- NCT00742716
- Run by
- OPKO IP Holdings II, Inc.
- People needed
- 41
- Starts
- 2008-10-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2014-11-06
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Body mass index between 18 and 35
- On maintenance hemodialysis three times per week
- Serum iPTH value greater than or equal to 300 pg/mL and lower than or equal to 1000 pg/mL
- Adjusted or total serum calcium value greater than or equal to 8.4 mg/dL and lower than 10.0 mg/dL
- Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL
- Serum 25-hydroxyvitamin D level greater than or equal to 15 ng/mL
- Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and the length of study
You may not qualify if…
- On bisphosphonates for at least three months prior to first dose of Study Drug
- Currently taking cytochrome P450 3A inhibitors and/or inducers
- Abnormal liver functions
Where it is running
- Pines Clinical Research, Inc. — Pembroke Pines, Florida, United States
- Boise Kidney and Hypertension Institute — Meridian, Idaho, United States
- Western New England Renal & Transplant Associates (WNERTA) — Springfield, Massachusetts, United States
- Southeast Renal Research Institute — Chattanooga, Tennessee, United States
- U.S. Renal Care — Fort Worth, Texas, United States
- Capital District Heatlth Authority: Centre for Clinical Research — Halifax, Nova Scotia, Canada
- St. Joseph's Health Care London — London, Ontario, Canada
- St. Michael's Hospital — Toronto, Ontario, Canada
- Humber River Regional Hospital — Weston, Ontario, Canada
- Hôpital Charles-Lemoyne — Greenfield Park, Quebec, Canada
- Hôpital du Sacré-Coeur de Montréal — Montreal, Quebec, Canada
- Hospital de Verdun — Verdun, Quebec, Canada
Full record on ClinicalTrials.gov
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