Chronic Kidney DiseaseNCT00785629
A Double Blind Randomized Placebo Trial of Maintenance of Normal Serum Phosphorus in CKD
A study testing Calcium acetate, Lanthanum Carbonate and Sevelamer Carbonate in people with Chronic Kidney Disease, run by Denver Nephrologists, P.C. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Calcium acetate, Lanthanum Carbonate and Sevelamer Carbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jul 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women > 18 years of age;
- Has signed and dated the most recent informed consent form approved by an IRB;
- Will, in the opinion of the PI, be compliant with prescribed phosphate binder therapy;
- Must be able to communicate with the investigator, and be able to understand and comply with the requirements of the study;
- Has a life expectancy >12 months;
- 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;
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- A screening serum phosphorus value > 3.5 mg/dL and ≤ 6.0 mg/dL;
- Must consume a minimum of 2 meals per day and be willing to avoid intentional changes in diet;
- Women of child bearing potential must be practicing an acceptable form of birth control.
Who cannot join
- Receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to baseline;
- Subject is pregnant, is breast feeding or is of child bearing potential and not using acceptable birth control measures;
- Has had a previous renal transplant;
- Has a chronic reliance on enemas or laxatives;
- Has a known sensitivity or previous intolerance to any of the products to be administered during the study;
- Clinical evidence of active malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous carcinoma of the skin;
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- Currently has an active infection or is being treated with antibiotics (within 14 days prior to baseline);
- Has been hospitalized within 30 days prior to baseline (with the exception of hospitalizations due to vascular access procedures);
- 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;
- Currently taking any of the following within 14 days prior to baseline; Calcitriol or its analogs, Cinacalcet hydrochloride, Medications prescribed for the purpose of phosphorus binding;
- Screening serum intact PTH >500 pg/mL;
- Screening corrected calcium < 8.0 mg/dL or > 10.4 mg/dL;
- Uncontrolled hyperlipidemia in the opinion of the PI;
- Initiation of chronic maintenance hemodialysis planned within 12 months;
- Relocation to another area planned within 12 months;
- Has a known history of immunodeficiency diseases, including a positive HIV test result;
- Active drug or alcohol dependence or abuse (excluding tobacco use) within the 12 months prior to dosing or evidence of such abuse;
- Evidence of active liver disease with AST or ALT levels greater than 3X the upper limit of normal;
- Has had a major cardiovascular event within 180 days of screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind Randomized Placebo Controlled Trial of Maintenance of Normal Serum Phosphorus in Chronic Kidney Disease (CKD)
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Calcium acetate, Lanthanum Carbonate, Sevelamer Carbonate, Placebo
- Keywords
- phosphorus, secondary hyperparathyroidism, vascular calcification
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium acetateDrug
Lanthanum CarbonateDrug
Also called Fosrenol
Sevelamer CarbonateDrug
Also called Renvela
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Calcium Acetate | Active comparator | 667 mg with meals Receives: Drug: Calcium acetate |
| Lanthanum Carbonate | Active comparator | 500 mg with meals Receives: Drug: Lanthanum Carbonate |
| Sevelamer Carbonate | Active comparator | 800 mg with meals Receives: Drug: Sevelamer Carbonate |
| Placebo | Placebo comparator | with meals Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Phosphorus
mean serum phosphorus from months 3-9
Measured: months 3-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startFeb 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Nephrologists, P.C.
- Sponsor type
- University, hospital or other
- Collaborators
- Shire, Fresenius Medical Care North America, Genzyme, a Sanofi Company, Novartis Pharmaceuticals, DaVita, Inc.
- Responsible party
- Sponsor
- Investigators
- Geoffrey A Block, MD, Principal investigator, Denver Nephrologists, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785629
- Sponsor's protocol ID
- PNT001
- Status last verified
- Sep 2012
- First submitted
- 4 Nov 2008
- Last updated
- 30 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PubMed 40576086Dougher CE, Rifkin DE, Anderson CA, Smits G, Persky MS, Block GA, Ix JH. Spot urine sodium measurements do not accurately estimate dietary sodium intake in chronic kidney disease. Am J Clin Nutr. 2016 Aug;104(2):298-305. doi: 10.3945/ajcn.115.127423. Epub 2016 Jun 29.
PubMed 27357090
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomized Placebo Controlled Trial of Maintenance of Normal Serum Phosphorus in Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT00785629
- Acronym / sponsor ID
- PNT001
- Conditions
- Chronic Kidney Disease
- Keywords
- phosphorus, secondary hyperparathyroidism, vascular calcification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Denver Nephrologists, P.C.University, hospital or other
- Collaborators
- Shire, Fresenius Medical Care North America, Genzyme, a Sanofi Company, Novartis Pharmaceuticals, DaVita, Inc.
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 5 Nov 2008 (estimated)
- Results
- Posted 30 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Calcium Acetate | Active comparator | Drug: Calcium acetate667 mg with meals |
| Lanthanum Carbonate | Active comparator | Drug: Lanthanum Carbonate500 mg with meals |
| Sevelamer Carbonate | Active comparator | Drug: Sevelamer Carbonate800 mg with meals |
| Placebo | Placebo comparator | Drug: Placebowith meals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or women > 18 years of age;
- Has signed and dated the most recent informed consent form approved by an IRB;
- Will, in the opinion of the PI, be compliant with prescribed phosphate binder therapy;
- Must be able to communicate with the investigator, and be able to understand and comply with the requirements of the study;
- Has a life expectancy >12 months;
Key exclusion criteria (19 listed)
- Receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to baseline;
- Subject is pregnant, is breast feeding or is of child bearing potential and not using acceptable birth control measures;
- Has had a previous renal transplant;
- Has a chronic reliance on enemas or laxatives;
- Has a known sensitivity or previous intolerance to any of the products to be administered during the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium acetate | Drug | Calcium Acetate |
| Lanthanum CarbonateAlso: Fosrenol | Drug | Lanthanum Carbonate |
| Sevelamer CarbonateAlso: Renvela | Drug | Sevelamer Carbonate |
| Placebo | Drug | Placebo |
Primary outcome
Serum Phosphorus
Time frame: months 3-9
mean serum phosphorus from months 3-9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40576086Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
- Derived from this study: PubMed 27357090Dougher CE, Rifkin DE, Anderson CA, Smits G, Persky MS, Block GA, Ix JH. Spot urine sodium measurements do not accurately estimate dietary sodium intake in chronic kidney disease. Am J Clin Nutr. 2016 Aug;104(2):298-305. doi: 10.3945/ajcn.115.127423. Epub 2016 Jun 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey A Block, MD principal investigator
Denver Nephrologists, PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium acetate, Lanthanum Carbonate and Sevelamer Carbonate in people with Chronic Kidney Disease, run by Denver Nephrologists, P.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Phosphorus (time frame: months 3-9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00785629, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2012.