CompletedPhase 1

Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)

United States24 participantsStarted 2008-11

Plain-language summary

This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths. This study will also investigate the levels of CTAP201 in the body over time and determine the safety of CTAP201.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Body mass index between 18 and 40 * On maintenance hemodialysis three times per week * Visit 1: Serum iPTH value greater than or equal to 200 pg/mL and lower than or equal to 1000 pg/mL * Visit 1: Serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL * Visit 1: 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 * Visit 2: Serum iPTH value greater than 300 pg/mL * Visit 2: Serum Ca x P product less than 56 \[mg/dl\]2 * Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and length of study Exclusion Criteria: * Taking cytochrome P450 3A inhibitors and/or inducers * Abnormal liver functions

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Blood levels of CTAP201 and doxercalciferol

Timeframe: Day 1 and Day 15 of each dose level

Safety of a single dose of CTAP201 Injection

Timeframe: Throughout the study

Trial details

NCT IDNCT00792857

SponsorOPKO IP Holdings II, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-09

View on ClinicalTrials.gov More Chronic Kidney Disease trials