Kidney Failure, Chronic Clinical Trial
Official title:
A Randomized, Active-Controlled, Double-Blind Multi-Center Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis
| NCT number | NCT00091481 |
| Other study ID # | M01-367 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | September 9, 2004 |
| Last updated | September 23, 2007 |
| Start date | June 2003 |
| Verified date | September 2007 |
| Source | Abbott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To show non-inferiority in the incidence rates of elevated calcium-phosphorus product between two treatment groups: 1) a group having an initial dose based on baseline PTH (baseline iPTH/80) and 2) a group having a starting dose based on body weight (0.04 mcg/kg).
| Status | Completed |
| Enrollment | 201 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - Stage V Chronic Kidney Disease - Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Greece | Errikos Dynan Hospital | Ambelokipi | Athens |
| Greece | Blue Cross Clinic | Athens | |
| Greece | Evgenidio Clinic | Athens | |
| Greece | Regional General Hospital of Athens "Korgialeneio-Benakeio" | Athens | |
| Greece | General University Hospital of Alexandroupolis | Dragana | |
| Greece | General Hospital Thessaloniki "Papanikolaou" | Exohi | Thessaloniki |
| Greece | General Hospital of Athens, "G.Gennimatas" | Holargos | Athens |
| Greece | General University Hospital Ioannina | Ioannina | |
| Greece | Regional General Hospital of Ioannina "Hatzikosta" | Ioannina | |
| Greece | "Hygeia" Diagnosis and Therapy Center | Marousi | Athens |
| Greece | General Hospital of Attica "Sismanoglio" | Marousi | Athens |
| Greece | General Hospital of Melissia "Amalia Fleming" | Melissia | Athens |
| Greece | General Hospital of Nikea "Agios Panteleimon" | Nikea, Piraeus 18454, | |
| Greece | General Hospital of Veria | Papagou Area | Veria |
| Greece | General Hospital of Thessaloniki "Ahepa" | Thessaloniki | |
| Greece | General Hospital of Thessaloniki "Hippokrateion" | Thessaloniki | |
| Greece | General Hospital of Thessaloniki "Papageorgiou" | Thessaloniki | |
| Greece | General Hospital of Voula Askilpieion | Voula | Athens |
| Greece | General Hospital of Heraklion | Voutes, Heraklion | Crete |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
Greece,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence rate of at least two consecutive calcium-phosphorus product levels greater than 65. | |||
| Secondary | Evaluate the number of days to achieve the first of 2 consecutive > or = 30% decreases from baseline in PTH | |||
| Secondary | The incidence rate for hypercalcemia | |||
| Secondary | The incidence rate for hyperphosphatemia |
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