Chronic Kidney DiseaseNCT00438932

Low Phosphate Diets in Patients With Early Stages of Chronic Kidney Disease

A study testing Lanthanum Carbonate, Low Phosphorus Diet and Unrestricted Phosphorus Diet in people with Chronic Kidney Disease, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to learn more about how the kidneys control the blood levels of phosphorus in patients with early chronic kidney disease. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Chronic Kidney Disease
What is being tested?: Lanthanum Carbonate, Low Phosphorus Diet and Unrestricted Phosphorus Diet
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 1 siteUnited States
Study dates: Jan 2007to Jan 2010
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

subjects with stage 3a, 3b and 4 CKD
subjects have to be aged 18 years or older
subjects have to have normal serum phosphate levels (< 4.6 mg/dl)
subjects have to have sufficient 25-OH Vit0amin D levels (≥ 20 ng/ml)

Who cannot join

subjects with rapidly advancing renal failure who thus might develop hyperphosphatemia or end stage renal disease requiring initiation of dialysis during the study period
subjects expected to require dialysis initiation within the follow up period
subjects with hyperphosphatemia > 4.6 mg/dL
subjects with any previous or current treatment with phosphate binders or active vitamin D (doxercalciferol or calcitriol)
subjects with malnutrition, defined as a serum albumin < 3.0 mg/dl, in order to avoid worsening protein-malnutrition status during the restricted study period since phosphate restricted diets are also low in protein
subjects with chronic gastrointestinal diseases that could impede their absorptive ability such as Crohn's disease, ulcerative colitis and sprue

Show all 16Show fewer

subjects with liver disease (ALT or AST > 100 U/L) or cholestasis (direct bilirubin > 1.0 mg/dl) because this can limit their ability to absorb fat soluble vitamins such as vitamin D
subjects with anemia, defined as a hematocrit <27% at the screening visit
subjects wht have been hospitalization within the previous 4 weeks
subjects who are pregnant
subjects who are breastfeeding mothers
subjects with primary hypoparathyroidism
subjects with primary hyperparathyroidism
subjects with previous subtotal parathyroidectomy
subjects with previous outpatient counseling by a renal nutritionist
subjects who are unable to independently provide written informed consent - prisoners, mentally incompetent, minors

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Reduced Phosphate Intake in "Normo-Phosphatemic" Chronic Kidney Disease Patients

Read the detailed description

Phosphorus is a mineral found in dairy products, nuts, and meat that is essential for bone health and many other important functions inside the body's cells. The kidneys are responsible for keeping the blood levels of phosphorus normal. Healthy kidneys do this by spilling excess phosphorus into the urine. In patients with chronic kidney disease, the kidneys are unable to spill an adequate amount of phosphorus so that excess phosphorus can accumulate in the walls of blood vessels leading to heart disease, their leading cause of death. A recently discovered hormone called FGF-23 helps control the blood levels of phosphorus by "telling" the kidney how much phosphorus to spill in the urine. The purpose of this study is to learn more about how FGF-23 helps the kidneys control the blood levels of phosphorus. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney disease.

Conditions: Chronic Kidney Disease
Being tested: Lanthanum Carbonate, Low Phosphorus Diet, Unrestricted Phosphorus Diet, Placebo
Keywords: phosphate, phosphorus, FGF-23, PTH, 1,25D
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lanthanum CarbonateDrug
Lanthanum carbonate 1000mg 3x/day
Low Phosphorus DietDietary supplement
Low phosphorus diet will consist of 800 mg of phosphorus per day.
Unrestricted Phosphorus DietDietary supplement
Also called Neutraphos
Unrestricted diet will contain 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
PlaceboDrug
Lanthanum Carbonate placebo given three times a day with meals.

Study groups in NCT00438932
Study group	Role	What they receive
Lanthanum Carbonate and Low Phosphorus Diet	Active comparator	25% of subjects will receive binders plus a phosphate restricted diet. Receives: Drug: Lanthanum Carbonate; Dietary Supplement: Low Phosphorus Diet
Lanthanum Carbonate and Unrestricted Phosphorus Diet	Active comparator	25% binders + unrestricted phosphate diet. Receives: Drug: Lanthanum Carbonate; Dietary Supplement: Unrestricted Phosphorus Diet
Placebo and Low Phosphorus Diet	Active comparator	25% placebo + phosphate restricted diet. Receives: Dietary Supplement: Low Phosphorus Diet; Drug: Placebo
Placebo and Unrestricted Phosphorus Diet	Active comparator	25% placebo + unrestricted phosphate diet. Receives: Dietary Supplement: Unrestricted Phosphorus Diet; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Fibroblast Growth Factor 23 (FGF-23)
Plasma FGF-23 was measured using c-terminal FGF23 assay.
Measured: 2 weeks

Secondary outcomes (1)

24-hour Urinary Phosphate
from 24-hr urine collections
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Jan 2010

First posted22 Feb 2007 (estimated)
Study startJan 2007
Primary completionJan 2010
Study completionJan 2010

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 (1)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
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: Factorial
Masking: Single blind
Who is masked: Participant
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00438932
Sponsor's protocol ID: 2005P000486
Status last verified: Sep 2011
First submitted: 20 Feb 2007
Last updated: 27 Sep 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Isakova T, Gutierrez OM, Smith K, Epstein M, Keating LK, Juppner H, Wolf M. Pilot study of dietary phosphorus restriction and phosphorus binders to target fibroblast growth factor 23 in patients with chronic kidney disease. Nephrol Dial Transplant. 2011 Feb;26(2):584-91. doi: 10.1093/ndt/gfq419. Epub 2010 Jul 14.
PubMed 20631407

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reduced Phosphate Intake in "Normo-Phosphatemic" Chronic Kidney Disease Patients
ClinicalTrials.gov ID: NCT00438932
Acronym / sponsor ID: 2005P000486
Conditions: Chronic Kidney Disease
Keywords: phosphate, phosphorus, FGF-23, PTH, 1,25D
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Shire
Study start: Jan 2007
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 22 Feb 2007 (estimated)
Results: Posted 27 Sep 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Lanthanum Carbonate and Low Phosphorus Diet	Active comparator	Drug: Lanthanum Carbonate, Dietary Supplement: Low Phosphorus Diet25% of subjects will receive binders plus a phosphate restricted diet.
Lanthanum Carbonate and Unrestricted Phosphorus Diet	Active comparator	Drug: Lanthanum Carbonate, Dietary Supplement: Unrestricted Phosphorus Diet25% binders + unrestricted phosphate diet.
Placebo and Low Phosphorus Diet	Active comparator	Dietary Supplement: Low Phosphorus Diet, Drug: Placebo25% placebo + phosphate restricted diet.
Placebo and Unrestricted Phosphorus Diet	Active comparator	Dietary Supplement: Unrestricted Phosphorus Diet, Drug: Placebo25% placebo + unrestricted phosphate diet.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

subjects with stage 3a, 3b and 4 CKD
subjects have to be aged 18 years or older
subjects have to have normal serum phosphate levels (< 4.6 mg/dl)
subjects have to have sufficient 25-OH Vit0amin D levels (≥ 20 ng/ml)

Key exclusion criteria (16 listed)

subjects with rapidly advancing renal failure who thus might develop hyperphosphatemia or end stage renal disease requiring initiation of dialysis during the study period
subjects expected to require dialysis initiation within the follow up period
subjects with hyperphosphatemia > 4.6 mg/dL
subjects with any previous or current treatment with phosphate binders or active vitamin D (doxercalciferol or calcitriol)
subjects with malnutrition, defined as a serum albumin < 3.0 mg/dl, in order to avoid worsening protein-malnutrition status during the restricted study period since phosphate restricted diets are also low in protein

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
Lanthanum CarbonateLanthanum carbonate 1000mg 3x/day	Drug	Lanthanum Carbonate and Low Phosphorus Diet, Lanthanum Carbonate and Unrestricted Phosphorus Diet
Low Phosphorus DietLow phosphorus diet will consist of 800 mg of phosphorus per day.	Dietary supplement	Lanthanum Carbonate and Low Phosphorus Diet, Placebo and Low Phosphorus Diet
Unrestricted Phosphorus DietAlso: NeutraphosUnrestricted diet will contain 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.	Dietary supplement	Lanthanum Carbonate and Unrestricted Phosphorus Diet, Placebo and Unrestricted Phosphorus Diet
PlaceboLanthanum Carbonate placebo given three times a day with meals.	Drug	Placebo and Low Phosphorus Diet, Placebo and Unrestricted Phosphorus Diet

Primary outcome

Fibroblast Growth Factor 23 (FGF-23)
Time frame: 2 weeks
Plasma FGF-23 was measured using c-terminal FGF23 assay.

1 secondary outcome

24-hour Urinary Phosphate
Time frame: 2 weeks

Results and safety

Results posted to the registry on 27 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lanthanum Carbonate & Low Phosphorous Diet	4	4
Lanthanum Carbonate & Unrestricted Phosphorous Diet	4	4
Placebo & Low Phosphorous Diet	4	4
Placebo & Unrestricted Phosphorous Diet	4	4

Primary outcome: Fibroblast Growth Factor 23 (FGF-23)

Time frame: 2 weeks. Mean (Standard Error). Unit: RU/ml

Measure	Lanthanum Carbonate & Low Phosphorous Diet n = 4	Lanthanum Carbonate & Unrestricted Phosphorous Diet n = 4	Placebo & Low Phosphorous Diet n = 4	Placebo & Unrestricted Phosphorous Diet n = 4
Value	162.695 (56.170737)	297 (77.69778)	188.975 (60.2020815)	143.7675 (37.507486)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lanthanum Carbonate & Low Phosphorous Diet	0 of 4 (0%)	0 of 4 (0%)	Not reported
Lanthanum Carbonate & Unrestricted Phosphorous Diet	0 of 4 (0%)	0 of 4 (0%)	Not reported
Placebo & Low Phosphorous Diet	0 of 4 (0%)	0 of 4 (0%)	Not reported
Placebo & Unrestricted Phosphorous Diet	0 of 4 (0%)	0 of 4 (0%)	Not reported

Limitations and caveats (from the sponsor): In addition to limited power, the small sample size led to imbalances in baseline laboratory tests, which added further variability to the analyses. .

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20631407Isakova T, Gutierrez OM, Smith K, Epstein M, Keating LK, Juppner H, Wolf M. Pilot study of dietary phosphorus restriction and phosphorus binders to target fibroblast growth factor 23 in patients with chronic kidney disease. Nephrol Dial Transplant. 2011 Feb;26(2):584-91. doi: 10.1093/ndt/gfq419. Epub 2010 Jul 14.

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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.

Myles Wolf, MD, MMSc principal investigator

Univesity of Miami Miller School of Medicine

Harald Jueppner, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lanthanum Carbonate, Low Phosphorus Diet and Unrestricted Phosphorus Diet in people with Chronic Kidney Disease, run by Massachusetts General Hospital 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 4 inclusion and 16 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 27 Sep 2011. 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. 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 27 Sep 2011). 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?

Fibroblast Growth Factor 23 (FGF-23) (time frame: 2 weeks). 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 NCT00438932, which also lists 1 linked publication.

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 27 Sep 2011.