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Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00975000
Recruitment Status : Completed
First Posted : September 11, 2009
Results First Posted : January 29, 2016
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Chronic Allograft Nephropathy
Chronic Kidney Disease
Chronic Renal Failure
Disordered Mineral Metabolism
End Stage Renal Disease
Hyperparathyroidism
Hypophosphatemia
Kidney Disease
Kidney Transplantation
Post Renal Transplantation
Interventions: Drug: Cinacalcet
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

This study was conducted at 33 centers in 11 countries (Australia, Austria, Belgium, Canada, France, Germany, Italy, Poland, Spain, Switzerland, and USA).

First patient enrolled on 15 October 2009 and last patient enrolled on 07 March 2012.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a 20-week titration phase, a 6-week efficacy assessment phase (EAP), a 26-week blinded maintenance phase and a 4-week follow-up phase. Randomization was stratified by corrected total serum calcium (Ca); enrollment into the low Ca stratum was limited to ≤70% of patients to ensure at least 30% enrollment in the high Ca stratum.

Reporting Groups
  Description
Placebo Participants received placebo orally once daily for 52 weeks.
Cinacalcet Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on intact parathyroid hormone (iPTH) values, corrected total serum calcium values, and safety assessments.

Participant Flow:   Overall Study
    Placebo   Cinacalcet
STARTED   57   57 
Completed Titration Phase   54   55 
Completed Efficacy Assessment Phase   54   54 
Completed Maintenance Phase   52   52 
COMPLETED   52 [1]   52 [1] 
NOT COMPLETED   5   5 
Other                1                0 
Adverse Event                1                1 
Withdrawal by Subject                2                2 
Lost to Follow-up                0                1 
Protocol-specified Criteria                1                0 
Non-compliance                0                1 
[1] Completed post-treatment follow-up phase



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Participants received placebo orally once daily for 52 weeks.
Cinacalcet Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
Total Total of all reporting groups

Baseline Measures
   Placebo   Cinacalcet   Total 
Overall Participants Analyzed 
[Units: Participants]
 57   57   114 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.7  (9.9)   53.0  (10.7)   52.3  (10.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      25  43.9%      26  45.6%      51  44.7% 
Male      32  56.1%      31  54.4%      63  55.3% 
Race/Ethnicity, Customized 
[Units: Participants]
     
White or Caucasian   46   47   93 
Black or African American   4   5   9 
Hispanic or Latino   1   2   3 
Asian   3   2   5 
Native Hawaiian or Other Pacific Islander   2   0   2 
Other   1   1   2 
Stratification Factor: Albumin-corrected Calcium Level 
[Units: Participants]
     
Corrected calcium ≤ 11.2 mg/dL   22   23   45 
Corrected calcium > 11.2 mg/dL   35   34   69 
Corrected Total Serum Calcium 
[Units: mg/dL]
Mean (Standard Deviation)
 11.31  (0.50)   11.28  (0.41)   11.29  (0.45) 
Intact Parathyroid Hormone 
[Units: pg/mL]
Mean (Standard Deviation)
 307.5  (180.5)   327.7  (262.6)   317.6  (224.5) 
Serum Phosphorus [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 2.48  (0.52)   2.66  (0.54)   2.57  (0.54) 
[1] Data available for 56 participants in each treatment group.
Estimated Glomerular Filtration Rate (eGFR) [1] 
[Units: mL/min/1.73 m²]
Mean (Standard Deviation)
 54.68  (14.79)   57.00  (17.31)   55.84  (16.07) 
[1] eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.


  Outcome Measures

1.  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)   [ Time Frame: Weeks 21 to 26 (EAP) ]

2.  Secondary:   Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck   [ Time Frame: Baseline and Week 52 ]

3.  Secondary:   Change From Baseline to the EAP in Mean Serum Phosphorus   [ Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26) ]

4.  Secondary:   Change From Baseline to Week 52 in eGFR   [ Time Frame: Baseline and Week 52 ]

5.  Secondary:   Change From Baseline to the EAP in Corrected Total Calcium   [ Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26) ]

6.  Secondary:   Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH)   [ Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26) ]

7.  Secondary:   Change From Baseline to the EAP in Urine Phosphorus   [ Time Frame: Baseline and the EAP (mean of Weeks 22, 24, and 26) ]

8.  Secondary:   Percentage of Participants With a Parathyroidectomy   [ Time Frame: 56 weeks ]

9.  Secondary:   Time to Parathyroidectomy   [ Time Frame: 56 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


Publications:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00975000     History of Changes
Other Study ID Numbers: 20062007
First Submitted: September 10, 2009
First Posted: September 11, 2009
Results First Submitted: December 23, 2015
Results First Posted: January 29, 2016
Last Update Posted: March 15, 2017