NCT00967629

Brief Summary

The purpose of this study is to determine whether oral sevelamer carbonate binds advanced glycation end products (AGEs) in the gastrointestinal (GI) tract of patients with diabetic nephropathy leading to decrease body AGE load and therefore decreases the inflammation and oxidative stress in these patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

November 18, 2011

Status Verified

November 1, 2011

Enrollment Period

8 months

First QC Date

August 26, 2009

Last Update Submit

November 16, 2011

Conditions

Diabetic Nephropathy

Keywords

Diabetic nephropathyCKD progressionAGEsoxidative stressdietary AGEs

Outcome Measures

Primary Outcomes (3)

  • serum AGE levels

    To compare the effect of Sevelamer Carbonate versus calcium carbonate on serum AGE levels in patients with stage II-IV chronic kidney disease resulting from diabetic nephropathy from baseline to 2 months and to 4 months later.

    baseline

  • serum AGE levels

    To compare the effect of Sevelamer Carbonate versus calcium carbonate on serum AGE levels in patients with stage II-IV chronic kidney disease resulting from diabetic nephropathy from baseline to 2 months and to 4 months later.

    at 2 months

  • serum AGE levels

    To compare the effect of Sevelamer Carbonate versus calcium carbonate on serum AGE levels in patients with stage II-IV chronic kidney disease resulting from diabetic nephropathy from baseline to 2 months and to 4 months later.

    at 4 months

Secondary Outcomes (3)

  • inflammatory markers

    baseline

  • inflammatory markers

    at 2 months

  • inflammatory markers

    at 4 months

Study Arms (2)

Sevelamer Carbonate crossover

OTHER

Participants will be patients with stage II-IV CKD due to diabetic nephropathy randomized to start either with sevelamer carbonate or calcium carbonate

Drug: Sevelamer Carbonate

Calcium Carbonate crossover

OTHER

Participants will be patients with stage II-IV CKD due to diabetic nephropathy randomized to start either with sevelamer carbonate or calcium carbonate

Drug: Calcium Carbonate

Interventions

Sevelamer CarbonateDRUG

This is a 4 month, prospective, comparative, crossover study. The study will be conducted in 20 patients with stage II, III or stage IV diabetic nephropathy. Patients will be randomized 1:1 to receive either 1,250 mg of calcium carbonate TID with meals (control arm) or Sevelamer Carbonate 1,600 mg (two 800 mg tablets) with meals. Each group of 10 subjects will take the assigned drug for 8 weeks. Following the 8 week treatment period, subjects will discontinue the assigned drug for a one week washout period. Following the washout period, those who were taking calcium carbonate will be crossed over to Sevelamer Carbonate therapy and those who were receiving Sevelamer Carbonate will be crossed over to calcium carbonate for a final 8 week treatment phase.

Sevelamer Carbonate crossover
Calcium CarbonateDRUG

This is a 4 month, prospective, comparative, crossover study. The study will be conducted in 20 patients with stage II, III or stage IV diabetic nephropathy. Patients will be randomized 1:1 to receive either 1,250 mg of calcium carbonate TID with meals (control arm) or Sevelamer Carbonate 1,600 mg (two 800 mg tablets) with meals. Each group of 10 subjects will take the assigned drug for 8 weeks. Following the 8 week treatment period, subjects will discontinue the assigned drug for a one week washout period. Following the washout period, those who were taking calcium carbonate will be crossed over to Sevelamer Carbonate therapy and those who were receiving Sevelamer Carbonate will be crossed over to calcium carbonate for a final 8 week treatment phase.

Calcium Carbonate crossover

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old
  • Evidence of CKD II, III or IV Stage II CKD: eGFR 60-89 cc/min Stage III CKD: eGFR 30-59 cc/min Stage IV CKD: eGFR 15-20 cc/min
  • Proteinuria on urinalysis on two occasions within 18 months of recruitment
  • Diagnosis of diabetes and receiving at least one medication for diabetes mellitus.

You may not qualify if:

  • Age \< 18 years old
  • Stage I and V CKD
  • Patients receiving active treatment for hyperphosphatemia.
  • Biopsy proven renal disease other than diabetic nephropathy
  • Hypophosphatemia
  • Hypercalcemia
  • any history of significant gastrointestinal disorders
  • any history of significant gastrointestinal surgery such as ileostomy, colostomy and colectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (4)

  • Uribarri J, Peppa M, Cai W, Goldberg T, Lu M, He C, Vlassara H. Restriction of dietary glycotoxins reduces excessive advanced glycation end products in renal failure patients. J Am Soc Nephrol. 2003 Mar;14(3):728-31. doi: 10.1097/01.asn.0000051593.41395.b9.

    PMID: 12595509BACKGROUND

  • Peppa M, Uribarri J, Cai W, Lu M, Vlassara H. Glycoxidation and inflammation in renal failure patients. Am J Kidney Dis. 2004 Apr;43(4):690-5. doi: 10.1053/j.ajkd.2003.11.022.

    PMID: 15042546BACKGROUND

  • Goldberg T, Cai W, Peppa M, Dardaine V, Baliga BS, Uribarri J, Vlassara H. Advanced glycoxidation end products in commonly consumed foods. J Am Diet Assoc. 2004 Aug;104(8):1287-91. doi: 10.1016/j.jada.2004.05.214.

    PMID: 15281050BACKGROUND

  • Uribarri J, Cai W, Peppa M, Goodman S, Ferrucci L, Striker G, Vlassara H. Circulating glycotoxins and dietary advanced glycation endproducts: two links to inflammatory response, oxidative stress, and aging. J Gerontol A Biol Sci Med Sci. 2007 Apr;62(4):427-33. doi: 10.1093/gerona/62.4.427.

    PMID: 17452738BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

SevelamerCalcium Carbonate

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic ChemicalsCalcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Helen Vlassara, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2009

First Posted

August 28, 2009

Study Start

June 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

November 18, 2011

Record last verified: 2011-11

Locations

US(1)