Phase 4
N=71
A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD)
Anemia · Secondary Hyperparathyroidism
Bottom Line
View on ClinicalTrials.gov: NCT00431496 ↗Enrolled (actual)
71
Serious AEs
38.0%
Results posted
Jul 2011
Primary outcome: Primary: Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2 — 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cinacalcet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2 |
30 | — |
| SECONDARY Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL |
37 | — |
| SECONDARY Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) |
56 | — |
| SECONDARY Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L |
39 | — |
| SECONDARY Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L |
38 | — |
| SECONDARY Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL |
33 | — |
Summary
The purpose of this study is to show that the use of cinacalcet in patients with End Stage Renal Disease can help achieve NKF K/DOQI targets for both serum calcium and calcium phosphorous product.
Eligibility Criteria
Inclusion Criteria
- Patients with ESRD requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month
- Being treated with Aranesp for anaemia management and have stabilised haemoglobin (Hb) levels. Hb stabilisation is defined as two consecutive Hb measurements during the screening period (that must include the most recent assessment) above 110 g/L.
- Males or females > 18 years of age at the time of informed consent
- Patients participating in this study must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study. Females must have a negative serum pregnancy test within 21 days before day 1 if they are of child-bearing potential
- The mean of 2 Intact parathyroid hormone (iPTH) determinations within 21 days before study day 1 and drawn at least 2 days apart must be > 31.8 pmol/L (300 pg/mL) and 2.1 mmol/L (8.4 mg/dL)
- Signed the Independent Ethics Committee (IEC) approved Informed Consent document, before ANY study specific procedures are initiated
Exclusion Criteria
- Have received vitamin D therapy for less than 21 days before day 1 or required a change in prescribed vitamin D brand or dose within 21 days before day 1. If patients are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for the 21 days before day 1
- Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator
- Hypersensitivity to Sensipar or any of its components
- Are currently breastfeeding
- Have had a parathyroidectomy in the 3 months before day 1
- Experienced a myocardial infarction within 3 months prior to day 1
- Have had a red blood cell transfusion within 3 months prior to day 1
- Are currently enrolled in, or have not yet completed at least 30 days before day 1 other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable)
- Have a gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets
- Have a disorder that would interfere with understanding and giving informed consent, or compliance with protocol requirements
- Have previously enrolled in this study or participated in other trials of Sensipar
Data sourced from ClinicalTrials.gov (NCT00431496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.