Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients

Chronic Kidney Disease Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Using Cinacalcet to Correct Hypercalcemia in Renal Transplant Recipients With Autonomous Hyperparathyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975000
• Other study ID #: 20062007
• Status: Completed
• Phase: Phase 3
• Start date: December 3, 2009
• Est. completion date: April 16, 2013

Study information

• Verified date: September 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck. Patients with HPT can develop bone disease (osteodystrophy). This bone disease can cause bone pain, fractures, and poor formation of red blood cells. Other problems from HPT may include increases in blood levels of calcium (hypercalcemia) and low blood levels of phosphorus (hypophosphatemia). The high calcium levels may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), heart and lung problems or kidney transplant dysfunction (worsening of kidney transplant function). The purpose of this study is to evaluate the effects of cinacalcet (Sensipar/Mimpara) on high calcium levels in the blood in patients with HPT after a kidney transplant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: April 16, 2013
• Est. primary completion date: September 13, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Received a kidney transplant = 9 weeks at time of Screening and = 24 months before first dose

• May be the first kidney transplant or a repeat kidney transplant.

• Subjects with a functional, stable kidney transplant, defined as MDRD estimated glomerular filtration rate (eGFR) = 30 mL/min/1.73 m² (chromic kidney disease stage 3 or better) at Screening.

• Men or women = 18 years at the start of Screening (ie, time of informed consent).

• Corrected total serum calcium > 10.5 mg/dL (2.63 mmol/L), defined as the mean of 2 values in Screening period.

• iPTH > 100 pg/mL (10.6 pmol/L), during the Screening period (obtained at either Screen 1 or Screen 2).

Exclusion Criteria:

• Received cinacalcet therapy post-transplant for more than 14 days cumulatively post-transplant. If cinacalcet therapy was received for a total of 14 days or less post-transplant, there must be a 4-week washout before subject is eligible for screening (Note: This does not exclude pre-transplant use of cinacalcet).

• Anticipated parathyroidectomy within 6 to12 months after Randomization.

• Ongoing therapy with bisphosphonates or use within 6 months prior to Screening.

• Ongoing use of 1,25-dihydroxyvitamin D3 (including other active vitamin D metabolites or analogues) or use within 30 days prior to Screening.

• Ongoing use of calcium supplements or use within 30 days prior to Screening.

• Ongoing use of phosphate binders (calcium or non-calcium containing) or use within 30 days prior to Screening.

• Ongoing use of a thiazide diuretic.

• Subjects with a history of seizures who had a seizure within the 3 months prior to Randomization, which required adjustments to the seizure medication.

• Acute Kidney Injury (AKI) or renal biopsy within 6 weeks prior to Screening, unless it is an institutional protocol-driven biopsy.

Related Conditions & MeSH terms

• Chronic Allograft Nephropathy
• Chronic Kidney Disease
• Chronic Renal Failure
• Disordered Mineral Metabolism
• End Stage Renal Disease
• Hypercalcemia
• Hyperparathyroidism
• Hypophosphatemia
• Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Kidney Transplantation
• Post Renal Transplantation
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Cinacalcet
Possible sequential doses are 30, 60, 90, 120, and 180 mg.
• Placebo
Administered orally following the same dosing regimen as the experimental arm.

Locations

Country	Name	City	State
Australia	Research Site	Camperdown	New South Wales
Australia	Research Site	Parkville	Victoria
Australia	Research Site	Westmead	New South Wales
Australia	Research Site	Woodville South	South Australia
Austria	Research Site	Wien
Belgium	Research Site	Brussels
Belgium	Research Site	Gent
Belgium	Research Site	Leuven
Canada	Research Site	Calgary	Alberta
Canada	Research Site	London	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
France	Research Site	Bordeaux Cedex
France	Research Site	Montpellier cedex 05
France	Research Site	Nantes Cedex 1
France	Research Site	Paris Cedex 15
France	Research Site	Toulouse Cedex 09
Germany	Research Site	Berlin
Germany	Research Site	Kiel
Italy	Research Site	Genova
Italy	Research Site	Milano
Italy	Research Site	Padova
Poland	Research Site	Gdansk
Poland	Research Site	Katowice
Poland	Research Site	Lodz
Poland	Research Site	Poznan
Poland	Research Site	Szczecin
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	L'Hospitalet de Llobregat	Cataluña
Spain	Research Site	Málaga	AndalucÃ-a
Spain	Research Site	Madrid
Switzerland	Research Site	Bern
Switzerland	Research Site	Geneva 14
Switzerland	Research Site	Zurich
United States	Research Site	Atlanta	Georgia
United States	Research Site	Aurora	Colorado
United States	Research Site	Bethlehem	Pennsylvania
United States	Research Site	Chicago	Illinois
United States	Research Site	Dallas	Texas
United States	Research Site	Detroit	Michigan
United States	Research Site	Evanston	Illinois
United States	Research Site	Gainesville	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Nashville	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Phoenix	Arizona
United States	Research Site	San Francisco	California
United States	Research Site	Springfield	Massachusetts
United States	Research Site	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  France,  Germany,  Italy,  Poland,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP)		Weeks 21 to 26 (EAP)
Secondary	Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck	Bone mineral density (BMD) was measured using dual X-ray absorptiometry (DXA).	Baseline and Week 52
Secondary	Change From Baseline to the EAP in Mean Serum Phosphorus		Baseline and the EAP (mean of Weeks 22, 24, and 26)
Secondary	Change From Baseline to Week 52 in eGFR	eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.	Baseline and Week 52
Secondary	Change From Baseline to the EAP in Corrected Total Calcium		Baseline and the EAP (mean of Weeks 22, 24, and 26)
Secondary	Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH)		Baseline and the EAP (mean of Weeks 22, 24, and 26)
Secondary	Change From Baseline to the EAP in Urine Phosphorus		Baseline and the EAP (mean of Weeks 22, 24, and 26)
Secondary	Percentage of Participants With a Parathyroidectomy		56 weeks
Secondary	Time to Parathyroidectomy		56 weeks

External Links

•   AmgenTrials clinical trials website