NCT00891813 is a Phase 4 clinical trial of Zemplar (paricalcitol) in Secondary Hyperparathyroidism, sponsored by Abbott.

Who is sponsoring NCT00891813?

NCT00891813 is sponsored by Abbott.

What drugs are being tested in NCT00891813?

Interventions in NCT00891813: Zemplar (paricalcitol).

What condition does NCT00891813 study?

NCT00891813 studies Secondary Hyperparathyroidism, Renal Insufficiency, Chronic, Parathyroid Hormone, Hemodialysis, Hypercalcemia.

Is NCT00891813 still recruiting?

NCT00891813 is currently completed. Last updated 22 September 2011.

Are results published for NCT00891813?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2011-09-22 · How we verify

NCT00891813

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effectiveness and Safety of a 6-Month Treatment With IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose

Completed Phase 4 Results posted Last updated 22 September 2011

What this trial tests

Phase 4 trial testing Zemplar (paricalcitol) in Secondary Hyperparathyroidism in 100 participants. Completed in 1 September 2010.

Timeline

1 May 2009

Primary endpoint
1 September 2010

1 September 2010

Quick facts

Lead sponsor	Abbott
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 May 2009
Primary completion	1 September 2010
Estimated completion	1 September 2010
Sites	3 locations across Peru

Drugs / interventions tested

Zemplar (paricalcitol)

Conditions studied

Secondary Hyperparathyroidism — all drugs for Secondary Hyperparathyroidism →
Renal Insufficiency, Chronic — all drugs for Renal Insufficiency, Chronic →
Parathyroid Hormone — all drugs for Parathyroid Hormone →
Hemodialysis — all drugs for Hemodialysis →

Sponsor

Abbott — full company profile →

Who can join

18 and older, any sex, with Secondary Hyperparathyroidism or Renal Insufficiency, Chronic. 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.

The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL
Time frame: 24 weeks
The percentage of participants who achieved at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150 to 300 picograms per milliliter (pg/mL) at any post-baseline visit during the study. An iPTH value of 150-300 pg/ml is the target range recommended by the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) for End Stage Re

Sponsor's own description

The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH\>300pg/mL) and that require dialysis at least 3 times per week.

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:

Other recruiting trials for Secondary Hyperparathyroidism

Currently open trials in the same condition.

NCT06130683 — Single-Cell Sequence Technology Used to Reveal Heterogeneity of Secondary Hyperparathyroidism · active not recruiting
NCT05880914 — Precision Medicine Approaches to Renal Osteodystrophy · recruiting
NCT03969329 — A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis · Phase 3 · recruiting
NCT03633708 — A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemo · Phase 3 · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00891813 (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: 22 September 2011

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/NCT00891813.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing