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NCT00667576
Late Phase 2 Study of Paricalcitol Injection: Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism (Examination of Initial Dose and Incremental Dose)
Phase 2 trial testing Maxacalcitol in Chronic Kidney Disease on Hemodialysis in 153 participants. Completed in 1 March 2009.
1 March 2009
Quick facts
| Lead sponsor | Abbott |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 153 |
| Start date | 1 April 2008 |
| Primary completion | 1 March 2009 |
| Estimated completion | 1 March 2009 |
| Sites | 12 locations across Japan |
Drugs / interventions tested
- Maxacalcitol (MAXACALCITOL) — full drug profile →
- Paricalcitol (PARICALCITOL) — full drug profile →
Conditions studied
- Chronic Kidney Disease on Hemodialysis — all drugs for Chronic Kidney Disease on Hemodialysis →
- Secondary Hyperparathyroidism — all drugs for Secondary Hyperparathyroidism →
Sponsor
Abbott — full company profile →
Who can join
20 and older, any sex, with Chronic Kidney Disease on Hemodialysis or Secondary Hyperparathyroidism. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Percentage of Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level
Time frame: Baseline to Week 13 (Final Visit)
Sponsor's own description
The purpose of this study was to investigate the initial dose and dose adjustment range for paricalcitol injection in patients with chronic kidney disease on hemodialysis who have secondary hyperparathyroidism.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00667576
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Kidney Disease on Hemodialysis
Currently open trials in the same condition.
- NCT07494695 — Experience of Young Adult Kidney Patients Requiring Haemodialysis · active not recruiting
Other Abbott trials
Trials by the same sponsor.
- NCT06217393 — Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia · Phase 3 · completed
- NCT05370703 — A Clinical Study to Evaluate the Effect of Mobile Applications "My A:Care" and "Smart Coach" on the Lipid-lowering Treat · completed
- NCT05519514 — Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects · Phase 1 · completed
- NCT04784208 — A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY) · unknown
- NCT05175131 — Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00667576 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Abbott
- Last refreshed: 18 January 2012
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00667576.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing