The Effects of Sevelamer Carbonate on Diabetic Nephropathy
Multi-Center Study of the Effect of Sevelamer Carbonate (Renvela®) on Metabolic/Inflammatory/ROS in Diabetics With Nephropathy
1 other identifier
interventional
117
1 country
2
Brief Summary
The purpose of this study is to see if taking a medication can lower the amount of oxidants from food that go into our body. Previous research shows that if the investigators lower the oxidants from food in people with diabetes, this simple change lowers different risks for heart disease and the worsening of kidney disease. The investigators focus on a specific type of oxidant, advanced glycation endproducts (AGEs). A previous, smaller study, conducted by our group showed that a drug, already approved by the FDA, will lower AGEs in the investigators compared Renvela® to Tums®. Both of these drugs have few side effects and have been used for a long time in patients with diabetes and kidney disease. While our previous study was interesting, it was just too small to be able to be sure that it will help all people with diabetes, or if the good effects the investigators found were simply due to chance. The investigators are doing this new study to confirm or deny the possibility that Renvela® can really help people with diabetes and kidney disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2011
CompletedFirst Posted
Study publicly available on registry
December 15, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedApril 9, 2014
April 1, 2014
1.8 years
December 13, 2011
April 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
glucose metabolism
HbA1C and serum AGE levels
baseline
glucose metabolism
HbA1C and serum AGE levels
at 3 months
glucose metabolism
HbA1C and serum AGE levels
at 6 months
Secondary Outcomes (8)
markers of inflammation and oxidative stress
baseline
markers of inflammation and oxidative stress
at 3 months
markers of inflammation and oxidative stress
at 6 months
serum lipid levels
baseline
serum lipid levels
at 3 months
- +3 more secondary outcomes
Study Arms (2)
Sevelamer Carbonate
EXPERIMENTAL1600 mg (two 800 mg in the form of tablets or powder to be diluted in water) TID with meals for 26 weeks
calcium carbonate
ACTIVE COMPARATOR1200 mg of calcium carbonate TID with meals for 26 weeks
Interventions
1600 mg (two 800 mg in the form of tablets or powder to be diluted in water) TID with meals for 26 weeks
1200 mg of calcium carbonate TID with meals for 26 weeks
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- Evidence of CKD Stages II, III or IV
- Stage II CKD; eGFR 60-89 ml/min
- Stage III CKD: eGFR 30-59 ml/min
- Stage IV CKD: eGFR 15-29 ml/min
- Proteinuria (\>200 mg/day or 300 mg/gm creatinine on a spot urine) on urinalysis on two occasions within 18 months of recruitment
- Diagnosis of diabetes and receiving at least one medication for diabetes mellitus
- HbA1c\>6.5%
You may not qualify if:
- Age \<18
- 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
- Gary Strikerlead
Study Sites (2)
Beth Israel Medical Center
New York, New York, 10003, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Related Publications (2)
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.
PMID: 40576086DERIVEDVlassara H, Uribarri J, Cai W, Goodman S, Pyzik R, Post J, Grosjean F, Woodward M, Striker GE. Effects of sevelamer on HbA1c, inflammation, and advanced glycation end products in diabetic kidney disease. Clin J Am Soc Nephrol. 2012 Jun;7(6):934-42. doi: 10.2215/CJN.12891211. Epub 2012 Mar 29.
PMID: 22461535DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Striker, MD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 13, 2011
First Posted
December 15, 2011
Study Start
February 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 9, 2014
Record last verified: 2014-04