Kidney Failure, ChronicPhase 2LEAPNCT00853242

Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis

A Phase 2 study testing Genz-644470 and Sevelamer carbonate in people with Kidney Failure, Chronic, run by Genzyme, a Sanofi Company at 53 sites in 2 countries.

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 clinical study is to compare the effects of Genz-644470 with the effects of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in hyperphosphatemic chronic kidney disease participants on hemodialysis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Failure, Chronic
What is being tested?: Genz-644470 and Sevelamer carbonate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 349 participants
Where: 53 sitesin 2 countries
Study dates: Feb 2009to Aug 2009
Phase: Phase 2
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

Serum phosphate level greater than (>) 5.5 milligram per deciliter (mg/dL) (1.78 millimole per liter [mmol/L]) after discontinuation of current phosphate binder therapy
Men or women 18 years or older

Who cannot join

Have active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation

Trial locations and contacts

53 sites in 2 countries.

Country

City, postcode or hospital

53 sites in 2 countries

United States52 sites

Study site
Alexander City, Alabama
Study site
Alexandria, Virginia
Study site
Asheville, North Carolina
Study site
Augusta, Georgia
Study site
Bakersfield, California
Study site
Bellmore, New York
Study site
Bethesda, Maryland
Study site
Birmingham, Alabama
Study site
Brookhaven, Mississippi
Study site
Brooklyn, New York
Study site
Buffalo, New York
Study site
Charleston, South Carolina
Study site
Cincinnati, Ohio
Study site
Columbia, Tennessee
Study site
Denver, Colorado
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Doylestown, Pennsylvania
Study site
Glendale, Wisconsin
Study site
Gulfport, Mississippi
Study site
Gurnee, Illinois
Study site
Hot Springs, Arkansas
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Houston, Texas
Study site
Hudson, Florida
Study site
Indianapolis, Indiana
Study site
Kearney, Nebraska
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Knoxville, Tennessee
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Lancaster, Pennsylvania
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Las Vegas, Nevada
Study site
Lewistown, Pennsylvania
Study site
Lexington, Kentucky
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Los Angeles, California
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Marietta, Georgia
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Milwaukee, Wisconsin
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Nashville, Tennessee
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New York, New York
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Ocala, Florida
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Orangeburg, South Carolina
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Paramount, California
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Pembroke Pines, California
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Philadelphia, Pennsylvania
Study site
Pontiac, Michigan
Study site
Port Washington, New York
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Porterville, California
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Riverside, California
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San Dimas, California
Study site
Southfield, Michigan
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St Louis, Missouri
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Sumter, South Carolina
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Tampa, Florida
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The Bronx, New York
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Washington D.C., District of Columbia
Study site
Whittier, California
Study site
Wichita, Kansas

Other trials in United States

Puerto Rico1 site

Study site
San Juan

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Using Genz-644470 and Sevelamer Carbonate in Hyperphosphatemic Chronic Kidney Disease Patients on Hemodialysis

Conditions: Kidney Failure, Chronic
Being tested: Placebo, Genz-644470, Sevelamer carbonate
Keywords: Chronic Kidney Disease, Phosphate Binder, Phosphate, Hyperphosphatemia
Medical subject headings: Kidney Failure, Chronic, Renal Insufficiency, Chronic, Hyperphosphatemia

What participants receive

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

PlaceboDrug
Genz-644470Drug
Sevelamer carbonateDrug
Also called Renvela®

Study groups in NCT00853242
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks. Receives: Drug: Placebo
Genz-644470 2.4 Grams Per Day (g/day)	Experimental	Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks. Receives: Drug: Genz-644470
Genz-644470 4.8 g/day	Experimental	Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks. Receives: Drug: Genz-644470
Genz-644470 7.2 g/day	Experimental	Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks. Receives: Drug: Genz-644470
Sevelamer Carbonate 2.4 g/day	Active comparator	Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks. Receives: Drug: Sevelamer carbonate
Sevelamer Carbonate 4.8 g/day	Active comparator	Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks. Receives: Drug: Sevelamer carbonate
Sevelamer Carbonate 7.2 g/day	Active comparator	Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks. Receives: Drug: Sevelamer carbonate

What is being measured

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

Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)
Measured: Baseline, Day 22

Secondary outcomes (4)

Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)
Measured: Baseline, Day 22
Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22
Measured: Baseline, Day 22
Change From Baseline in Total Cholesterol at Day 22
Measured: Baseline, Day 22
Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22
Measured: Baseline, Day 22

Timeline

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

Feb 2009Aug 2009

First posted2 Mar 2009 (estimated)
Study startFeb 2009
Primary completionAug 2009
Study completionAug 2009

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 Kidney Failure, ChronicStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 349 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00853242
Sponsor's protocol ID: APB00108
Acronym: LEAP
Status last verified: Apr 2015
First submitted: 27 Feb 2009
Last updated: 1 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 40576086

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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All Kidney Failure, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Using Genz-644470 and Sevelamer Carbonate in Hyperphosphatemic Chronic Kidney Disease Patients on Hemodialysis
ClinicalTrials.gov ID: NCT00853242
Acronym / sponsor ID: LEAP / APB00108
Conditions: Kidney Failure, Chronic
Keywords: Chronic Kidney Disease, Phosphate Binder, Phosphate, Hyperphosphatemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 349 participants (actual)
Lead sponsor: Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 2 Mar 2009 (estimated)
Results: Posted 1 May 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
Genz-644470 2.4 Grams Per Day (g/day)	Experimental	Drug: Genz-644470Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470 4.8 g/day	Experimental	Drug: Genz-644470Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470 7.2 g/day	Experimental	Drug: Genz-644470Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 2.4 g/day	Active comparator	Drug: Sevelamer carbonateSevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 4.8 g/day	Active comparator	Drug: Sevelamer carbonateSevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 7.2 g/day	Active comparator	Drug: Sevelamer carbonateSevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.

Who may qualify

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

Key inclusion criteria (2 listed)

Serum phosphate level greater than (>) 5.5 milligram per deciliter (mg/dL) (1.78 millimole per liter [mmol/L]) after discontinuation of current phosphate binder therapy
Men or women 18 years or older

Key exclusion criteria (1 listed)

Have active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation

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
Placebo	Drug	Placebo
Genz-644470	Drug	Genz-644470 2.4 Grams Per Day (g/day), Genz-644470 4.8 g/day, Genz-644470 7.2 g/day
Sevelamer carbonateAlso: Renvela®	Drug	Sevelamer Carbonate 2.4 g/day, Sevelamer Carbonate 4.8 g/day, Sevelamer Carbonate 7.2 g/day

Primary outcome

Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)
Time frame: Baseline, Day 22

4 secondary outcomes

Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)
Time frame: Baseline, Day 22
Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22
Time frame: Baseline, Day 22
Change From Baseline in Total Cholesterol at Day 22
Time frame: Baseline, Day 22
Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22
Time frame: Baseline, Day 22

Results and safety

Results posted to the registry on 1 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	50	47
Genz-644470 2.4 Grams Per Day (g/Day)	50	47
Genz-644470 4.8 g/Day	49	46
Genz-644470 7.2 g/Day	50	46
Sevelamer Carbonate 2.4 g/Day	50	46
Sevelamer Carbonate 4.8 g/Day	51	49
Sevelamer Carbonate 7.2 g/Day	49	44

Primary outcome: Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)

Time frame: Baseline, Day 22. Mean (Standard Deviation). Unit: mg/dL

Measure	Placebo n = 50	Genz-644470 2.4 g/Day n = 48	Genz-644470 4.8 g/Day n = 47	Genz-644470 7.2 g/Day n = 46
Value	-0.0 (1.3)	-0.6 (1.5)	-1.2 (1.6)	-1.8 (1.9)

Placebo vs Genz-644470 2.4 g/Day: p = 0.0249, Wilcoxon Rank Sum Tests
Placebo vs Genz-644470 4.8 g/Day: p = 0.0001, Wilcoxon Rank Sum Tests
Placebo vs Genz-644470 7.2 g/Day: p <0.0001, Wilcoxon Rank Sum Tests

Population analysed: Full Analysis Set (FAS) included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure less than or equal to (\<=) 3 days after date of last study drug.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 50 (8%)	17 of 50 (34%)	Not reported
Genz-644470 2.4 g/Day	2 of 49 (4.1%)	17 of 49 (34.7%)	Not reported
Genz-644470 4.8 g/Day	6 of 48 (12.5%)	17 of 48 (35.4%)	Not reported
Genz-644470 7.2 g/Day	6 of 50 (12%)	25 of 50 (50%)	Not reported
Sevelamer Carbonate 2.4 g/Day	8 of 50 (16%)	22 of 50 (44%)	Not reported
Sevelamer Carbonate 4.8 g/Day	5 of 51 (9.8%)	25 of 51 (49%)	Not reported
Sevelamer Carbonate 7.2 g/Day	5 of 48 (10.4%)	22 of 48 (45.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
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.

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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.

Medical Monitor study director

Genzyme, a Sanofi Company

53 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Genz-644470 and Sevelamer carbonate in people with Kidney Failure, Chronic, run by Genzyme, a Sanofi Company at 53 sites in 2 countries.

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 2 inclusion and 1 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 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Puerto Rico. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2015). 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?

Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo) (time frame: Baseline, Day 22). 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 NCT00853242, 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 1 May 2015.