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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03246984 -
VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
|
N/A | |
Completed |
NCT02922361 -
Spending and Outcomes for Complex Medicare Advantage Patients
|
||
Completed |
NCT02235571 -
iChoose Decision Kidney Aid for End-Stage Renal Disease Patients
|
N/A | |
Completed |
NCT01930396 -
Use of Tinzaparin for Anticoagulation in Hemodialysis
|
Phase 4 | |
Completed |
NCT01922843 -
A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
|
Phase 2 | |
Completed |
NCT01933789 -
Improving Communication About Serious Illness
|
N/A | |
Not yet recruiting |
NCT01674660 -
Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients
|
N/A | |
Completed |
NCT01209403 -
Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients
|
Phase 4 | |
Not yet recruiting |
NCT01157260 -
The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease
|
Phase 4 | |
Completed |
NCT00753116 -
Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension
|
Phase 1 | |
Recruiting |
NCT00532688 -
N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure
|
Phase 2/Phase 3 | |
Completed |
NCT00534144 -
Comparison Between Effects of Two Iron Preparations on Protein in the Urine
|
Phase 1 | |
Completed |
NCT00528788 -
How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
|
Phase 4 | |
Completed |
NCT00382044 -
Audit of the Effect of Changing From IV to SC Administration of ESA's in Haemodialysis Patients
|
N/A | |
Completed |
NCT00226902 -
Vascular Reactivity in Kidney Disease Patients
|
N/A | |
Recruiting |
NCT00235287 -
Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease
|
Phase 4 | |
Completed |
NCT00224081 -
DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)
|
Phase 4 | |
Completed |
NCT00071214 -
Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis
|
Phase 3 | |
Completed |
NCT00049907 -
Cardiac and Renal Disease Study (CARDS)
|
N/A | |
Completed |
NCT00006297 -
Risk Factors for CV Disease in a Dialysis Cohort
|
N/A |