A Study to Investigate the Safety and Efficacy of a Recombinant Human Parathyroid Hormone, for the Treatment of Adults With Hypoparathyroidism (RELAY)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

NPS Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01268098

First received: December 28, 2010

Last updated: October 1, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 28, 2010

Last Updated Date

October 1, 2012

Start Date ^ICMJE

January 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

A reduction in oral calcium supplementation to ≤ 500 mg/day, a reduction in calcitriol dose to ≤ 0.25 µg/day, and an albumin-corrected total serum calcium level between 7.5 mg/dL and the upper limit of normal. [ Time Frame: 8 Weeks of Dosing ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01268098 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

A ≥ 50% reduction from baseline in oral calcium supplementation, a ≥ 50% reduction from baseline in oral calcitriol supplementation and, an albumin-corrected total serum calcium concentration normalized or maintained compared to baseline value [ Time Frame: 8 Weeks of Dosing ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study to Investigate the Safety and Efficacy of a Recombinant Human Parathyroid Hormone, for the Treatment of Adults With Hypoparathyroidism (RELAY)

Official Title ^ICMJE

A Randomized, Dose-blinded Study to Investigate the Safety and Efficacy of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)], at Fixed Doses of 25 µg and 50 µg for the Treatment of Adults With Hypoparathyroidism

Brief Summary

Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and vitamin D supplements.

Detailed Description

Patients with a history of Hypoparathyroidism will be randomized to receive study drug for 8 weeks, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically calcium levels in blood or urine). In addition, the patients' intake of Vitamin D and Calcium will be measured.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Hypoparathyroidism

Intervention ^ICMJE

Drug: NPSP558

All patients will inject NPSP558 25 or 50 µg SC QD into alternating thighs in the morning via a multidose injection pen device.

Other Name: RELAY

Study Arm (s)

Experimental: 25 µg dose
25 µg

Intervention: Drug: NPSP558
Experimental: 50 µg dose
50 µg

Intervention: Drug: NPSP558

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Main Inclusion Criteria:

Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study
With regard to female patients: women who are postmenopausal or willing to use two medically acceptable methods of contraception for the duration of the study with pregnancy testing conducted at every scheduled office visit
Total serum calcium ≤ ULN based on local laboratory results prior to randomization
Serum 25(OH) vitamin D ≤ 1.5 times the ULN within approximately 8 weeks prior to randomization

Main Exclusion Criteria:

Any disease or condition that, in the opinion of the investigator, has a high probability of precluding the patient from completing the study or being able to appropriately comply with study requirements
Use of raloxifene hydrochloride or intravenous (IV) bisphosphonates since the end of participation in the REPLACE trial
Chronic (ie, ≥ 1 month exposure) use of systemic corticosteroids, oral bisphosphonates, calcitonin, fluoride tablets, or cinacalcet hydrochloride
Pregnant or lactating women
Any condition that would, in the investigator's opinion in consultation with the sponsor, preclude the safe use of PTH
Use of any experimental drug other than NPSP558 within 3 months of baseline.

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01268098

Other Study ID Numbers ^ICMJE

PAR-C10-007

Has Data Monitoring Committee

Responsible Party

NPS Pharmaceuticals

Study Sponsor ^ICMJE

NPS Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Hjalmar Lagast, M.D.

NPS Pharmaceuticals

Information Provided By

NPS Pharmaceuticals

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top