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Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Kenneth R. Phelps, M.D., Phelps, Kenneth R., M.D.
ClinicalTrials.gov Identifier:
NCT01191762
First received: August 27, 2010
Last updated: July 30, 2014
Last verified: July 2014
Results First Received: November 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Hyperparathyroidism
Chronic Kidney Disease
Interventions: Drug: sevelamer carbonate
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with eGFR < 60 were recruited from renal clinics and randomized to receive 3 tablets of sevelamer or placebo with each meal for four weeks.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomization was preceded by a 4-week course of vitamin D (dose determined by plasma [25OHD]) and then by a 4-week period of dietary phosphate restriction. The phosphate restriction was continued through the therapeutic trial.

Reporting Groups
  Description
Sevelamer Carbonate

2400 mg (3 pills) with each meal

sevelamer carbonate : 2400 mg with each meal for 4 weeks

Placebo Control

3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.

placebo : 3 tablets with each meal


Participant Flow:   Overall Study
    Sevelamer Carbonate     Placebo Control  
STARTED     15     15  
COMPLETED     14 [1]   15  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  
[1] One subject dropped out on the 3rd treatment day because of gastrointestinal complaints.



  Baseline Characteristics
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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.
Post-treatment data were not obtained from patient who withdrew on third treatment day.

Reporting Groups
  Description
Sevelamer Carbonate

2400 mg (3 pills) with each meal

sevelamer carbonate : 2400 mg with each meal for 4 weeks

Placebo Control

3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.

placebo : 3 tablets with each meal

Total Total of all reporting groups

Baseline Measures
    Sevelamer Carbonate     Placebo Control     Total  
Number of Participants  
[units: participants]
  14     15     29  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     6     9  
>=65 years     11     9     20  
Age  
[units: years]
Mean ± Standard Deviation
  73.7  ± 8.5     70.1  ± 10.5     71.8  ± 9.6  
Gender  
[units: participants]
     
Female     0     0     0  
Male     14     15     29  
Region of Enrollment  
[units: participants]
     
United States     14     15     29  



  Outcome Measures

1.  Primary:   Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate   [ Time Frame: 4 weeks ]

2.  Secondary:   Linear Regression of [PTH] on Phosphate Excretion Per Volume of Glomerular Filtrate (EP/Ccr)   [ Time Frame: at 12 and 16 weeks of trial (pre- and post-treatment) ]
Results not yet reported.   Anticipated Reporting Date:   07/2014   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
All intended measurements were made. The desired number of participants was recruited.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Kenneth R. Phelps, M.D.
Organization: Kenneth R. Phelps, M.D.
phone: 518-626-5641
e-mail: kenneth.phelps@va.gov


No publications provided


Responsible Party: Kenneth R. Phelps, M.D., Phelps, Kenneth R., M.D.
ClinicalTrials.gov Identifier: NCT01191762     History of Changes
Other Study ID Numbers: PhelpsK
Study First Received: August 27, 2010
Results First Received: November 13, 2013
Last Updated: July 30, 2014
Health Authority: United States: Institutional Review Board