Diabetic NephropathyPhase 1NCT00967629
Effect of Sevelamer Carbonate on Oxidative Stress in Patients With Diabetic Nephropathy
A Phase 1 study testing Sevelamer Carbonate and Calcium Carbonate in people with Diabetic Nephropathy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- Sevelamer Carbonate and Calcium Carbonate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Feb 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
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.
Read the detailed description
Traditional vascular risk factors alone cannot account for the elevated cardiovascular risk in patients with chronic kidney disease (CKD). In addition to a high prevalence of hypertension and diabetes, patients with CKD have elevated levels of inflammatory markers and OS, which are emerging as important risk factors for cardiovascular disease (CVD). Patients with CKD are also known to have elevated levels of circulating advanced glycation end products (AGE's), which have been shown to induce OS and to play a central role in the development of diabetic microvascular and macrovascular complications. In CKD patients, AGE's accumulate secondary to decreased renal clearance and increased endogenous production in the setting of high levels of OS. Efforts to understand relationships between the multiple vascular risk factors in chronic kidney disease may lead to reduced morbidity and mortality in this population of patients.
Sevelamer Hydrochloride is an anion exchange resin composed of multiple positively charged amine groups indicated for the treatment of hyperphosphatemia in patients with stage V CKD. The positively charged amine groups bind negatively charged dietary phosphate preventing systemic absorption. Sevelamer Hydrochloride has been shown to have the added benefits of lowering LDL levels, lowering highly sensitive C-reactive protein (hsCRP) levels, and improving insulin resistance. Patients treated with Sevelamer Hydrochloride have also been shown to have improved vascular compliance and reduced progression of coronary vascular calcification. Since AGE's are mostly negatively charged compounds, Sevelamer Carbonate by analogy, may have anti-AGE effects which could reduce inflammation and oxidative stress. Sevelamer Carbonate would have a major advantage over Calcium Carbonate-based phosphate binders, based on the fact that it would have the added advantage of reducing the levels of AGEs. The resultant reduction of both OS and inflammation would be expected to have an independent beneficial effect on the rate of progression of CKD and CVD.
We have shown in CKD patients and in animal models that AGE's correlate with levels of OS, LDL, hsCRP, and insulin resistance. Additionally, these factors can be remediated in CKD and non-CKD diabetics by decreasing overall AGE load, particularly in the diet. To date, the effect of Sevelamer Hydrochloride or Sevelamer Carbonate on OS and circulating AGE levels has not been studied. The anti-inflammatory and lipid-lowering effects of Sevelamer Hydrochloride may occur through lowering serum AGE levels and OS. Sevelamer Carbonate is an improved form of Sevelamer Hydrochloride that has been shown to be a safe and effective alternative to calcium carbonate in the treatment of hyperphosphatemia in the earlier sta'ges of CKD without causing metabolic acidosis. The development of Sevelamer Carbonate provides an opportunity to study patients with earlier stages of CKD, and to determine if it prevents or slows the progression of CKD. We propose a study designed to compare the effects of calcium carbonate and of Sevelamer Carbonate on serum AGE levels and OS in patients with stage II-IV diabetic nephropathy.
Hypothesis:
Sevelamer Carbonate administration in persons with stage II-IV CKD, compared with calcium carbonate administration, will result in at least a:
- 20% decrease in serum levels of AGE's;
- 10% decease in inflammatory markers of CRP and VCAM-1, or of OS (AGER1/RAGE) in circulating mononuclear cells.
- Conditions
- Diabetic Nephropathy
- Being tested
- Sevelamer Carbonate, Calcium Carbonate
- Keywords
- Diabetic nephropathy, CKD progression, AGEs, oxidative stress, dietary AGEs
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Calcium Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: at 4 months
Secondary outcomes (3)
inflammatory markers
To compare the effect of sevelamer carbonate versus calcium carbonate on markers of inflammation, oxidative stress, and serum lipid levels in patients with stage II-IV CKD resulting from diabetic nephropathy.
Measured: baseline
inflammatory markers
To compare the effect of sevelamer carbonate versus calcium carbonate on markers of inflammation, oxidative stress, and serum lipid levels in patients with stage II-IV CKD resulting from diabetic nephropathy.
Measured: at 2 months
inflammatory markers
To compare the effect of sevelamer carbonate versus calcium carbonate on markers of inflammation, oxidative stress, and serum lipid levels in patients with stage II-IV CKD resulting from diabetic nephropathy.
Measured: at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen Vlassara, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967629
- Sponsor's protocol ID
- GCO 08-0976
- Status last verified
- Nov 2011
- First submitted
- 26 Aug 2009
- Last updated
- 18 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12595509Peppa 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.
PubMed 15042546Goldberg 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.
PubMed 15281050Uribarri 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.
PubMed 17452738
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sevelamer Carbonate on Oxidative Stress in Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT00967629
- Acronym / sponsor ID
- GCO 08-0976
- Conditions
- Diabetic Nephropathy
- Keywords
- Diabetic nephropathy, CKD progression, AGEs, oxidative stress, dietary AGEs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Not posted in the source record
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 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.
Detailed description
Traditional vascular risk factors alone cannot account for the elevated cardiovascular risk in patients with chronic kidney disease (CKD). In addition to a high prevalence of hypertension and diabetes, patients with CKD have elevated levels of inflammatory markers and OS, which are emerging as important risk factors for cardiovascular disease (CVD). Patients with CKD are also known to have elevated levels of circulating advanced glycation end products (AGE's), which have been shown to induce OS and to play a central role in the development of diabetic microvascular and macrovascular complications. In CKD patients, AGE's accumulate secondary to decreased renal clearance and increased endogenous production in the setting of high levels of OS. Efforts to understand relationships between the multiple vascular risk factors in chronic kidney disease may lead to reduced morbidity and mortality in this population of patients.
Sevelamer Hydrochloride is an anion exchange resin composed of multiple positively charged amine groups indicated for the treatment of hyperphosphatemia in patients with stage V CKD. The positively charged amine groups bind negatively charged dietary phosphate preventing systemic absorption. Sevelamer Hydrochloride has been shown to have the added benefits of lowering LDL levels, lowering highly sensitive C-reactive protein (hsCRP) levels, and improving insulin resistance. Patients treated with Sevelamer Hydrochloride have also been shown to have improved vascular compliance and reduced progression of coronary vascular calcification. Since AGE's are mostly negatively charged compounds, Sevelamer Carbonate by analogy, may have anti-AGE effects which could reduce inflammation and oxidative stress. Sevelamer Carbonate would have a major advantage over Calcium Carbonate-based phosphate binders, based on the fact that it would have the added advantage of reducing the levels of AGEs. The resultant reduction of both OS and inflammation would be expected to have an independent beneficial effect on the rate of progression of CKD and CVD.
We have shown in CKD patients and in animal models that AGE's correlate with levels of OS, LDL, hsCRP, and insulin resistance. Additionally, these factors can be remediated in CKD and non-CKD diabetics by decreasing overall AGE load, particularly in the diet. To date, the effect of Sevelamer Hydrochloride or Sevelamer Carbonate on OS and circulating AGE levels has not been studied. The anti-inflammatory and lipid-lowering effects of Sevelamer Hydrochloride may occur through lowering serum AGE levels and OS. Sevelamer Carbonate is an improved form of Sevelamer Hydrochloride that has been shown to be a safe and effective alternative to calcium carbonate in the treatment of hyperphosphatemia in the earlier sta'ges of CKD without causing metabolic acidosis. The development of Sevelamer Carbonate provides an opportunity to study patients with earlier stages of CKD, and to determine if it prevents or slows the progression of CKD. We propose a study designed to compare the effects of calcium carbonate and of Sevelamer Carbonate on serum AGE levels and OS in patients with stage II-IV diabetic nephropathy.
Hypothesis:
Sevelamer Carbonate administration in persons with stage II-IV CKD, compared with calcium carbonate administration, will result in at least a:
- 20% decrease in serum levels of AGE's;
- 10% decease in inflammatory markers of CRP and VCAM-1, or of OS (AGER1/RAGE) in circulating mononuclear cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevelamer Carbonate crossover | Other | Drug: Sevelamer CarbonateParticipants will be patients with stage II-IV CKD due to diabetic nephropathy randomized to start either with sevelamer carbonate or calcium carbonate |
| Calcium Carbonate crossover | Other | Drug: Calcium CarbonateParticipants will be patients with stage II-IV CKD due to diabetic nephropathy randomized to start either with sevelamer carbonate or calcium carbonate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Age < 18 years old
- Stage I and V CKD
- Patients receiving active treatment for hyperphosphatemia.
- Biopsy proven renal disease other than diabetic nephropathy
- Hypophosphatemia
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 |
|---|---|---|
| Sevelamer CarbonateThis 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. | Drug | Sevelamer Carbonate crossover |
| Calcium CarbonateThis 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. | Drug | Calcium Carbonate crossover |
Primary outcome
serum AGE levels
Time frame: baseline
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.
serum AGE levels
Time frame: at 2 months
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.
serum AGE levels
Time frame: at 4 months
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.
3 secondary outcomes
inflammatory markers
Time frame: baseline
inflammatory markers
Time frame: at 2 months
inflammatory markers
Time frame: at 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2011.
- Background: PubMed 12595509Uribarri 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.
- Background: PubMed 15042546Peppa 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.
- Background: PubMed 15281050Goldberg 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.
- Background: PubMed 17452738Uribarri 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.
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Diabetic Nephropathies MeSH:D003928, Diabetes Mellitus, Type 2
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.
Helen Vlassara, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sevelamer Carbonate and Calcium Carbonate in people with Diabetic Nephropathy, run by Icahn School of Medicine at Mount Sinai 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 8 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 18 Nov 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 AGE levels (time frame: baseline). The study lists 3 primary outcomes in all. 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 NCT00967629, which also lists 4 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 18 Nov 2011.