Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NPS Pharma
ClinicalTrials.gov Identifier:
NCT01268098
First received: December 28, 2010
Last updated: March 10, 2015
Last verified: March 2015

December 28, 2010
March 10, 2015
January 2011
September 2011   (final data collection date for primary outcome measure)
Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
The triple efficacy endpoint criteria were defined as a reduction from baseline in oral calcium to ≤ 500 mg/day, a reduction from baseline 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 the laboratory normal range. The analysis of primary endpoint was based on investigator prescribed data.
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 ]
Complete list of historical versions of study NCT01268098 on ClinicalTrials.gov Archive Site
The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data
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 ]
Not Provided
Not Provided
 
Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypoparathyroidism
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
  • Experimental: 25 µg dose
    25 µg
    Intervention: Drug: NPSP558
  • Experimental: 50 µg dose
    50 µg
    Intervention: Drug: NPSP558
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
November 2011
September 2011   (final data collection date for primary outcome measure)

Main Inclusion Criteria:

  1. Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study
  2. 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
  3. Total serum calcium ≤ ULN based on local laboratory results prior to randomization
  4. Serum 25(OH) vitamin D ≤ 1.5 times the ULN within approximately 8 weeks prior to randomization

Main Exclusion Criteria:

  1. 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
  2. Use of raloxifene hydrochloride or intravenous (IV) bisphosphonates since the end of participation in the REPLACE trial
  3. Chronic (ie, ≥ 1 month exposure) use of systemic corticosteroids, oral bisphosphonates, calcitonin, fluoride tablets, or cinacalcet hydrochloride
  4. Pregnant or lactating women
  5. Any condition that would, in the investigator's opinion in consultation with the sponsor, preclude the safe use of PTH
  6. Use of any experimental drug other than NPSP558 within 3 months of baseline.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01268098
PAR-C10-007
No
NPS Pharma
NPS Pharma
Not Provided
Study Director: Hjalmar Lagast, M.D. NPS Pharma
NPS Pharma
March 2015

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