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A Double Blind Randomized Placebo Trial of Maintenance of Normal Serum Phosphorus in CKD
This study is currently recruiting participants.
Verified by Denver Nephrologists, P.C., March 2009
First Received: November 4, 2008   Last Updated: March 9, 2009   History of Changes
Sponsors and Collaborators: Denver Nephrologists, P.C.
Shire Pharmaceutical Development
Fresenius Medical Care North America
Genzyme
Information provided by: Denver Nephrologists, P.C.
ClinicalTrials.gov Identifier: NCT00785629
  Purpose

The purpose of this study is to determine the ability of 3 commercially available phosphorus binders (calcium acetate, sevelamer carbonate, and lanthanum carbonate) to achieve and maintain a phosphorus level in the normal range in patients with chronic kidney disease.


Condition Intervention
Chronic Kidney Disease
Drug: phosphate binder

Drug Information available for: Acetic acid, calcium salt Sevelamer Lanthanum Carbonate Sevelamer hydrochloride Sevelamer carbonate Phosphorus
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Double Blind Randomized Placebo Controlled Trial of Maintenance of Normal Serum Phosphorus in Chronic Kidney Disease (CKD)

Further study details as provided by Denver Nephrologists, P.C.:

Primary Outcome Measures:
  • serum phosphorus [ Time Frame: baseline, month 1, month 2, month 3, month 6, month 9 and month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • vascular calcification [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 195
Study Start Date: February 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sevelamer carbonate: Active Comparator Drug: phosphate binder
starting dose 800mg, titrations to 3200mg QAC
Drug: phosphate binder
starting dose 800mg; titrations to 3200mg QAC
sevelamer carbonate: Placebo Comparator Drug: phosphate binder
starting dose 800mg, titrations to 3200mg QAC
Drug: phosphate binder
starting dose 800mg; titrations to 3200mg QAC
Calcium acetate: Active Comparator Drug: phosphate binder
starting dose 667mg;titrations to 2668mg QAC
Drug: phosphate binder
starting dose 667mg; titrations to 2668mg QAC
calcium acetate: Placebo Comparator Drug: phosphate binder
starting dose 667mg;titrations to 2668mg QAC
Drug: phosphate binder
starting dose 667mg; titrations to 2668mg QAC
lanthanum carbonate: Active Comparator Drug: phosphate binder
starting dose 500mg; titration to 1500mg QAC
Drug: phosphate binder
starting dose 500mg; titrations to 1500mg QAC
Lanthanum carbonate: Placebo Comparator Drug: phosphate binder
starting dose 500mg; titration to 1500mg QAC
Drug: phosphate binder
starting dose 500mg; titrations to 1500mg QAC

Detailed Description:

It is the specific aim of this pilot study to assess the feasibility of achieving and maintaining a serum P less than or equal to 3.5 mg/dL (1.13 mmol/L) in patients with eGFR >20 and <45 mL/min with any of the 3 commercially available P lowering agents (calcium acetate, sevelamer carbonate, or lanthanum carbonate). Results of this study will clarify the degree of separation in serum P that can be achieved with the use of P lowering agents and the current standard of care (P binder initiation when P > 5.5 mg/dL or 1.78 mmol/L). Furthermore, this knowledge, combined with analyses of the secondary aims and outcomes of interest, will serve to facilitate the design of a properly powered, randomized, placebo controlled clinical outcomes trial that will firmly establish the necessity of achieving a specific target P in patients with CKD. The secondary aims of this pilot study are to provide insight into the optimal detection of progression of abnormalities in mineral metabolism and their relationship to vascular disease in CKD. The tertiary aim is to evaluate long term outcomes related to phosphorus normalization with respect to renal replacement therapy or death.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women > 18 years of age;
  2. Has signed and dated the most recent informed consent form approved by an IRB;
  3. Will, in the opinion of the PI, be compliant with prescribed phosphate binder therapy;
  4. Must be able to communicate with the investigator, and be able to understand and comply with the requirements of the study;
  5. Has a life expectancy >12 months;
  6. An eGFR rate (estimated by the MDRD equation) ≥ 20 and ≤ 45 mL/min/1.73m2 obtained by screening laboratory values and in the opinion of the investigator felt to have CKD without evidence of recent acute kidney injury or unexpected decline in renal function;
  7. Two phosphorus measures in the range of > 3.5 mg/dL and ≤ 6.0 mg/dL during screening;
  8. Must consume a minimum of 2 meals per day and be willing to avoid intentional changes in diet;
  9. Women of child bearing potential must be practicing an acceptable form of birth control.

Exclusion Criteria:

  1. Receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to baseline;
  2. An episode of acute kidney injury in the last 90 days;
  3. Subject is pregnant, is breast feeding or is of child bearing potential and not using acceptable birth control measures;
  4. Exceeds the weight of the EBCT scanner (> 350 lbs.);
  5. Active atrial fibrillation or atrial flutter;
  6. Has known primary hyperparathyroidism;
  7. Has had a previous renal transplant;
  8. Has a chronic reliance on enemas or laxatives;
  9. Has a known sensitivity or previous intolerance to any of the products to be administered during the study;
  10. Clinical evidence of active malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous carcinoma of the skin;
  11. Currently has an active infection or is being treated with antibiotics (within 14 days prior to screening);
  12. Has been hospitalized within 30 days prior to baseline (with the exception of hospitalizations due to vascular access procedures);
  13. Any surgical or medical condition which might significantly alter the function of phosphorus binders or which may jeopardize the subject in case of participation in the study. The investigator should be guided by evidence of any of the following: Severe gastrointestinal motility disorder,Bowel obstruction,Dysphagia or other disorders of swallowing, Acute peptic ulcer, Ulcerative colitis or Crohn's disease, History of major gastrointestinal tract surgery, Severe malabsorption;
  14. Currently taking any of the following within 30 days prior to baseline; Calcitriol or its analogs, Cinacalcet hydrochloride, Medications prescribed for the purpose of phosphorus binding;
  15. Screening serum intact PTH >500 pg/mL;
  16. Screening corrected calcium out of the normal range;
  17. Screening labs that indicate uncontrolled hyperlipidemia in the opinion of the PI;
  18. Initiation of chronic maintenance hemodialysis planned within 12 months;
  19. Relocation to another area planned within 12 months;
  20. Has a known history of immunodeficiency diseases, including a positive HIV test result;
  21. Active drug or alcohol dependence or abuse (excluding tobacco use) within the 12 months prior to dosing or evidence of such abuse;
  22. .Evidence of active liver disease with AST or ALT levels greater than 3X the upper limit of normal;
  23. Has had a major cardiovascular event within 180 days of screening.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785629

Contacts
Contact: martha s persky, BS, RN, CCRP 303-364-4775 mpersky@denverneph.net

Locations
United States, Colorado
Denver Nephrologists, PC Recruiting
Denver, Colorado, United States, 80230
Contact: martha S Persky, BS, RN, CCRP     303-364-4775     mpersky@denverneph.net    
Sponsors and Collaborators
Denver Nephrologists, P.C.
Shire Pharmaceutical Development
Fresenius Medical Care North America
Genzyme
Investigators
Principal Investigator: Geoffrey A Block, MD Denver Nephrologists, PC
  More Information

No publications provided

Responsible Party: Denver Nephrologists, PC ( Geoffrey A. Block )
Study ID Numbers: PNT001
Study First Received: November 4, 2008
Last Updated: March 9, 2009
ClinicalTrials.gov Identifier: NCT00785629     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Denver Nephrologists, P.C.:
phosphorus
secondary hyperparathyroidism
vascular calcification

Study placed in the following topic categories:
Sevelamer
Renal Insufficiency
Hyperparathyroidism, Secondary
Urologic Diseases
Hyperparathyroidism
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Neoplasm Metastasis
Kidney Diseases
Calcium acetate
Kidney Failure

Additional relevant MeSH terms:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on May 06, 2009