End-Stage Renal DiseaseFrEDINCT01116947
Fosrenol for Enhancing Dietary Protein Intake in Hypoalbuminemic Dialysis Patients (FrEDI) Study
A study of End-Stage Renal Disease, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
Trial summary
Protein-energy wasting, as reflected by a serum albumin <4.0 g/dL, is very common in maintenance hemodialysis (MHD) patients and associated with poor clinical outcomes including high death rates. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End-Stage Renal Disease
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Feb 2012
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prevalent hypoalbuminemic hemodialysis patients with a serum albumin <4.0 g/dL and capable of oral food intake
- Adult (18-85 years) hemodialysis patients for 3 months or longer, capable of eating food independently
- Protein energy wasting as evident by serum albumin <4.0 g/dL
- Not receiving Fosrenol for the past 2 weeks
Who cannot join
- Not willing to sign the written consent form
- Any condition that can interfere with increasing dietary protein intake, e.g. inability to eat or to maintain ingested food (OK to be on vitamin D agents including paricalcitol, calcitriol, doxercalciferol, ergocalciferol and cholecalciferol; or cinacalcet)
About this study
Official title: Fosrenol for Enhancing Dietary Protein Intake in Hypoalbuminemic Dialysis Patients (FrEDI) Study: An Investigator Initiated Study
Protein-energy wasting, as reflected by a serum albumin <4.0 g/dL, is very common in maintenance hemodialysis (MHD) patients and associated with poor clinical outcomes including high death rates. Hyperphosphatemia, reflected by serum phosphorus level >5.5 mg/dL, is also common disorder and associated with increased death risk in the same population. The traditional dietary intervention to control hyperphosphatemia is to restrict protein intake. This, however, may worsen protein-energy wasting as recently showed in large epidemiologic data, which indicated that the best survival was observed in MHD patients with increased protein intake while serum phosphorus could be controlled. We hypothesize that the provision of high protein diet will be possible if a potent phosphorus binder (Fosreonl™) will be prescribed simultaneously. Hence, we propose to conduct a randomized controlled trial in 110 hypoalbuminemic (albumin <4.0 mg/dL) MHD patients in several DaVita dialysis facilities in Los Angeles South Bay area. After 1:1 randomization, we will provide the participating subjects (the INTERVENTION group) with 8 weeks of high protein meals in form of prepared meal boxes (50 g protein, 850 Cal, and a phosphorus to protein ratio of <10 mg/gm) during each hemodialysis treatment, along with 0.5 to 1.5 g Fosrenol, to be titrated if necessary; as well as dietary counselling to maintain a high dietary protein intake at home (with same or similar binder regimen) for 8 weeks and to avoid food items with high phosphorus based additives. Meals will be prepared at Harbor-UCLA GCRC Bio-nutrition Department. We have reviewed and tested the feasibility of meal preparation and distribution system and the related logistics. The CONTROL group will also receive meal boxes but the meal contains low Calorie (<50 Cal) and almost zero protein (<1 g) diet (such as salads) during each hemodialysis treatment. These patients will continue their pre-existing phosphorus control regimens. As outcome variables, we will examine change in serum albumin over the 8 weeks of intervention. We will also examine changes in dietary protein and serum phosphorus in the 2 groups after 8 weeks of intervention. Quality of life and patient satisfaction will also be examined before and towards the end of the intervention phase. Given our ongoing 2-year study with a similar operation known as the AIONID Study and given DaVita dieticians'' collaboration and support, we anticipate successful recruitment, retention and data analyses within 8 to 12 months.
Read the detailed description
RATIONALE:
Based on the hypothesis that the efficacy and potency of Fosrenol enables increasing dietary protein intake and provision of meals during dialysis treatment for improving nutritional status in malnourished dialysis patients with a low serum albumin (<4.0 g/dL) while serum phosphorus can be effectively controlled with the target range of 3.5 to 5.5 mg/dL.
STUDY PROCEDURE:
- In all subjects: Recommend adequate dietary protein intake to achieve or maintain an nPCR (nPNA) above 1.0 g/kg/day for 2 months. Encourage aggressive increase in protein intake while avoiding high phos/protein ratio esp. higher intake of egg whites, meat, fish, poultries, legumes, etc. via counseling by renal dietician (RD) and/or study staff.
- Both groups will receive free meal boxes during the first 60 min of HD treatment for 8 weeks (24 meals during 24 HD treatment sessions). Cases will receive high protein meals (~50 gm, with phos/protein ratio <10 mg//gm), whereas controls will receive salad with almost no protein.
- In CASES (n=55): Switch binder simultaneously to (or start) Fosrenol 500 mg to 1,500 per meal/snack, according to the meal size at different times of the day. Recommend crushing the pills using the pill-crusher that will be provided to subjects, and recommend placing or sprinkling Fosrenol pieces on the food. Titrate the dose every 2 weeks according to serum phosphorus.
- In CONTROLLS (n=55): Continue the same binder (other than Fosrenol). In All subjects: Titrate the binder as indicated to control serum phosphorus <5.5 mg/dL.
SAFETY ENDPOINTS:
- Routine safety measures for food ingestion and binder administration
- Bi-weekly measures of minerals and monthly measures of PTH
STATISTICAL METHODS:
The t test, the chi square test, and the Mann-Whitney rank sum test to compare the baseline characteristics of intervention and control participants in serum albumin and other measures. To simplify presentation of results, some Likert scale responses will be dichotomized. The corresponding P values will be based on the complete ordinal scales used by participants to respond to questions quality of life, satisfaction, and food intake and about how often they eat meals from specific fast-food restaurants.
- Conditions
- End-Stage Renal Disease
- Being tested
- Meals during hemodialysis accompanied by lanthanum carbonate to control phosphorus
- Keywords
- Hypoalbuminemia, Hyperphosphatemia, Phosphorus, Protein, CKD, Dialysis, Meals, Lanthanum, End-Stage Renal Disease (ESRD), Dietary Protein Intake (DPI), Dietary Phosphorus Binding (DPB), Protein-Energy Wasting (PEW), Sources of Dietary Phosphorus
- Medical subject headings
- Kidney Failure, Chronic, Hypoalbuminemia, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meals during hemodialysis accompanied by lanthanum carbonate to control phosphorusOther
Based on the hypothesis that the efficacy and potency of Fosrenol enables increasing dietary protein intake and provision of meals during dialysis treatment for improving nutritional status in malnourished dialysis patients with a low serum albumin (<4.0 g/dL) while serum phosphorus can be effectively controlled with the target range of 3.5 to 5.5 mg/dL
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Active comparator | 1. Treatment Arm (CASES) will receive high protein meals during thrice weekly hemodialysis in-center (each meal includes ~50 g of protein, ~850 Cal, and phos/protein ratio <10 mg/g) PLUS dietary counseling to continue similar high protein intake with low phosphorus to protein ratio and to avoid foods with high preservative content. Fosrenol 1.0 to 1.5 g per meal will be prescribed (use of pill crusher will be recommended) and will be titrated based on bi-weekly phosphorus levels. Receives: Other: Meals during hemodialysis accompanied by lanthanum carbonate to control phosphorus |
| Control Arm (CONTROLS) | Active comparator | 2. Control Arm (CONTROLS) will receive salad boxes in-center (no protein, low calorie) and routine dietary counseling and will continue pre-existing phosphorus binder regimen. Receives: Other: Meals during hemodialysis accompanied by lanthanum carbonate to control phosphorus |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Change in serum albumin by +0.2 g/dl or higher over 2 months, i.e., from baseline (Month 0) to Month 2 (main outcome measure)
Measured: 2 months
Secondary outcomes (8)
2. Percentage of serum phosphorus between 3.5 and 5.5 mg/dL
Measured: 2 months
3. Change in nPCR (nPNA) by +0.1 g/kg/day
Measured: 2 months
4. Change in protein intake via food frequency questionnaire x 2 (baseline vs. after 2 months)
Measured: 2 months
5. Change in post-dialysis dry weight
Measured: 2 months
6. Changes in calcium, PTH, and alkaline phosphatase
Measured: 2 months
7. Patients satisfaction and quality of life (KDQOL36)
Measured: 2 months
8. RD and MD satisfaction per questionnaires
Measured: 2 months
9. Change in other nutritional or inflammatory markers (CRP, TIBC, MIS, SGA)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- DaVita, Inc., Shire
- Responsible party
- Principal investigator, kamyar kalantar-zadeh, md phd mph, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- Kamyar Kalantar-Zadeh, MD, MPH, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116947
- Sponsor's protocol ID
- LABioMed 13892-01
- Acronym
- FrEDI
- Status last verified
- Feb 2012
- First submitted
- 3 May 2010
- Last updated
- 29 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kovesdy CP, Anderson JE, Kalantar-Zadeh K. Outcomes associated with serum phosphorus level in males with non-dialysis dependent chronic kidney disease. Clin Nephrol. 2010 Apr;73(4):268-75. doi: 10.5414/cnp73268.
PubMed 20353734Noori N, Kalantar-Zadeh K, Kovesdy CP, Bross R, Benner D, Kopple JD. Association of dietary phosphorus intake and phosphorus to protein ratio with mortality in hemodialysis patients. Clin J Am Soc Nephrol. 2010 Apr;5(4):683-92. doi: 10.2215/CJN.08601209. Epub 2010 Feb 25.
PubMed 20185606Kalantar-Zadeh K, Gutekunst L, Mehrotra R, Kovesdy CP, Bross R, Shinaberger CS, Noori N, Hirschberg R, Benner D, Nissenson AR, Kopple JD. Understanding sources of dietary phosphorus in the treatment of patients with chronic kidney disease. Clin J Am Soc Nephrol. 2010 Mar;5(3):519-30. doi: 10.2215/CJN.06080809. Epub 2010 Jan 21.
PubMed 20093346Shinaberger CS, Greenland S, Kopple JD, Van Wyck D, Mehrotra R, Kovesdy CP, Kalantar-Zadeh K. Is controlling phosphorus by decreasing dietary protein intake beneficial or harmful in persons with chronic kidney disease? Am J Clin Nutr. 2008 Dec;88(6):1511-8. doi: 10.3945/ajcn.2008.26665.
PubMed 19064510Noori N, Sims JJ, Kopple JD, Shah A, Colman S, Shinaberger CS, Bross R, Mehrotra R, Kovesdy CP, Kalantar-Zadeh K. Organic and inorganic dietary phosphorus and its management in chronic kidney disease. Iran J Kidney Dis. 2010 Apr;4(2):89-100.
PubMed 20404416Kovesdy CP, Kalantar-Zadeh K. Bone and mineral disorders in pre-dialysis CKD. Int Urol Nephrol. 2008;40(2):427-40. doi: 10.1007/s11255-008-9346-7.
PubMed 18368510Kalantar-Zadeh K, Kuwae N, Regidor DL, Kovesdy CP, Kilpatrick RD, Shinaberger CS, McAllister CJ, Budoff MJ, Salusky IB, Kopple JD. Survival predictability of time-varying indicators of bone disease in maintenance hemodialysis patients. Kidney Int. 2006 Aug;70(4):771-80. doi: 10.1038/sj.ki.5001514. Epub 2006 Jul 5.
PubMed 16820797Shinaberger CS, Kilpatrick RD, Regidor DL, McAllister CJ, Greenland S, Kopple JD, Kalantar-Zadeh K. Longitudinal associations between dietary protein intake and survival in hemodialysis patients. Am J Kidney Dis. 2006 Jul;48(1):37-49. doi: 10.1053/j.ajkd.2006.03.049.
PubMed 16797385Mehrotra R, Martin KJ, Fishbane S, Sprague SM, Zeig S, Anger M; Fosrenol Overview Research Evaluation Study for Early Experience Study Group. Higher strength lanthanum carbonate provides serum phosphorus control with a low tablet burden and is preferred by patients and physicians: a multicenter study. Clin J Am Soc Nephrol. 2008 Sep;3(5):1437-45. doi: 10.2215/CJN.04741107. Epub 2008 Jun 25.
PubMed 18579668
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fosrenol for Enhancing Dietary Protein Intake in Hypoalbuminemic Dialysis Patients (FrEDI) Study: An Investigator Initiated Study
- ClinicalTrials.gov ID
- NCT01116947
- Acronym / sponsor ID
- FrEDI / LABioMed 13892-01
- Conditions
- End-Stage Renal Disease
- Keywords
- Hypoalbuminemia, Hyperphosphatemia, Phosphorus, Protein, CKD, Dialysis, Meals, Lanthanum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Collaborators
- DaVita, Inc., Shire
- Study start
- Jul 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 5 May 2010 (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.
Protein-energy wasting, as reflected by a serum albumin <4.0 g/dL, is very common in maintenance hemodialysis (MHD) patients and associated with poor clinical outcomes including high death rates. Hyperphosphatemia, reflected by serum phosphorus level >5.5 mg/dL, is also common disorder and associated with increased death risk in the same population. The traditional dietary intervention to control hyperphosphatemia is to restrict protein intake. This, however, may worsen protein-energy wasting as recently showed in large epidemiologic data, which indicated that the best survival was observed in MHD patients with increased protein intake while serum phosphorus could be controlled. We hypothesize that the provision of high protein diet will be possible if a potent phosphorus binder (Fosreonl™) will be prescribed simultaneously. Hence, we propose to conduct a randomized controlled trial in 110 hypoalbuminemic (albumin <4.0 mg/dL) MHD patients in several DaVita dialysis facilities in Los Angeles South Bay area. After 1:1 randomization, we will provide the participating subjects (the INTERVENTION group) with 8 weeks of high protein meals in form of prepared meal boxes (50 g protein, 850 Cal, and a phosphorus to protein ratio of <10 mg/gm) during each hemodialysis treatment, along with 0.5 to 1.5 g Fosrenol, to be titrated if necessary; as well as dietary counselling to maintain a high dietary protein intake at home (with same or similar binder regimen) for 8 weeks and to avoid food items with high phosphorus based additives. Meals will be prepared at Harbor-UCLA GCRC Bio-nutrition Department. We have reviewed and tested the feasibility of meal preparation and distribution system and the related logistics. The CONTROL group will also receive meal boxes but the meal contains low Calorie (<50 Cal) and almost zero protein (<1 g) diet (such as salads) during each hemodialysis treatment. These patients will continue their pre-existing phosphorus control regimens. As outcome variables, we will examine change in serum albumin over the 8 weeks of intervention. We will also examine changes in dietary protein and serum phosphorus in the 2 groups after 8 weeks of intervention. Quality of life and patient satisfaction will also be examined before and towards the end of the intervention phase. Given our ongoing 2-year study with a similar operation known as the AIONID Study and given DaVita dieticians'' collaboration and support, we anticipate successful recruitment, retention and data analyses within 8 to 12 months.
Detailed description
RATIONALE:
Based on the hypothesis that the efficacy and potency of Fosrenol enables increasing dietary protein intake and provision of meals during dialysis treatment for improving nutritional status in malnourished dialysis patients with a low serum albumin (<4.0 g/dL) while serum phosphorus can be effectively controlled with the target range of 3.5 to 5.5 mg/dL.
STUDY PROCEDURE:
- In all subjects: Recommend adequate dietary protein intake to achieve or maintain an nPCR (nPNA) above 1.0 g/kg/day for 2 months. Encourage aggressive increase in protein intake while avoiding high phos/protein ratio esp. higher intake of egg whites, meat, fish, poultries, legumes, etc. via counseling by renal dietician (RD) and/or study staff.
- Both groups will receive free meal boxes during the first 60 min of HD treatment for 8 weeks (24 meals during 24 HD treatment sessions). Cases will receive high protein meals (~50 gm, with phos/protein ratio <10 mg//gm), whereas controls will receive salad with almost no protein.
- In CASES (n=55): Switch binder simultaneously to (or start) Fosrenol 500 mg to 1,500 per meal/snack, according to the meal size at different times of the day. Recommend crushing the pills using the pill-crusher that will be provided to subjects, and recommend placing or sprinkling Fosrenol pieces on the food. Titrate the dose every 2 weeks according to serum phosphorus.
- In CONTROLLS (n=55): Continue the same binder (other than Fosrenol). In All subjects: Titrate the binder as indicated to control serum phosphorus <5.5 mg/dL.
SAFETY ENDPOINTS:
- Routine safety measures for food ingestion and binder administration
- Bi-weekly measures of minerals and monthly measures of PTH
STATISTICAL METHODS:
The t test, the chi square test, and the Mann-Whitney rank sum test to compare the baseline characteristics of intervention and control participants in serum albumin and other measures. To simplify presentation of results, some Likert scale responses will be dichotomized. The corresponding P values will be based on the complete ordinal scales used by participants to respond to questions quality of life, satisfaction, and food intake and about how often they eat meals from specific fast-food restaurants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Active comparator | Other: Meals during hemodialysis accompanied by lanthanum carbonate to control phosphorus1. Treatment Arm (CASES) will receive high protein meals during thrice weekly hemodialysis in-center (each meal includes ~50 g of protein, ~850 Cal, and phos/protein ratio <10 mg/g) PLUS dietary counseling to continue similar high protein intake with low phosphorus to protein ratio and to avoid foods with high preservative content. Fosrenol 1.0 to 1.5 g per meal will be prescribed (use of pill crusher will be recommended) and will be titrated based on bi-weekly phosphorus levels. |
| Control Arm (CONTROLS) | Active comparator | Other: Meals during hemodialysis accompanied by lanthanum carbonate to control phosphorus2. Control Arm (CONTROLS) will receive salad boxes in-center (no protein, low calorie) and routine dietary counseling and will continue pre-existing phosphorus binder regimen. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prevalent hypoalbuminemic hemodialysis patients with a serum albumin <4.0 g/dL and capable of oral food intake
- Adult (18-85 years) hemodialysis patients for 3 months or longer, capable of eating food independently
- Protein energy wasting as evident by serum albumin <4.0 g/dL
- Not receiving Fosrenol for the past 2 weeks
Key exclusion criteria (2 listed)
- Not willing to sign the written consent form
- Any condition that can interfere with increasing dietary protein intake, e.g. inability to eat or to maintain ingested food (OK to be on vitamin D agents including paricalcitol, calcitriol, doxercalciferol, ergocalciferol and cholecalciferol; or cinacalcet)
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 |
|---|---|---|
| Meals during hemodialysis accompanied by lanthanum carbonate to control phosphorusBased on the hypothesis that the efficacy and potency of Fosrenol enables increasing dietary protein intake and provision of meals during dialysis treatment for improving nutritional status in malnourished dialysis patients with a low serum albumin (<4.0 g/dL) while serum phosphorus can be effectively controlled with the target range of 3.5 to 5.5 mg/dL | Other | Control Arm (CONTROLS), Intervention Arm |
Primary outcome
1. Change in serum albumin by +0.2 g/dl or higher over 2 months, i.e., from baseline (Month 0) to Month 2 (main outcome measure)
Time frame: 2 months
8 secondary outcomes
2. Percentage of serum phosphorus between 3.5 and 5.5 mg/dL
Time frame: 2 months
3. Change in nPCR (nPNA) by +0.1 g/kg/day
Time frame: 2 months
4. Change in protein intake via food frequency questionnaire x 2 (baseline vs. after 2 months)
Time frame: 2 months
5. Change in post-dialysis dry weight
Time frame: 2 months
6. Changes in calcium, PTH, and alkaline phosphatase
Time frame: 2 months
7. Patients satisfaction and quality of life (KDQOL36)
Time frame: 2 months
8. RD and MD satisfaction per questionnaires
Time frame: 2 months
9. Change in other nutritional or inflammatory markers (CRP, TIBC, MIS, SGA)
Time frame: 2 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 29 Feb 2012.
- Background: PubMed 20353734Kovesdy CP, Anderson JE, Kalantar-Zadeh K. Outcomes associated with serum phosphorus level in males with non-dialysis dependent chronic kidney disease. Clin Nephrol. 2010 Apr;73(4):268-75. doi: 10.5414/cnp73268.
- Background: PubMed 20185606Noori N, Kalantar-Zadeh K, Kovesdy CP, Bross R, Benner D, Kopple JD. Association of dietary phosphorus intake and phosphorus to protein ratio with mortality in hemodialysis patients. Clin J Am Soc Nephrol. 2010 Apr;5(4):683-92. doi: 10.2215/CJN.08601209. Epub 2010 Feb 25.
- Background: PubMed 20093346Kalantar-Zadeh K, Gutekunst L, Mehrotra R, Kovesdy CP, Bross R, Shinaberger CS, Noori N, Hirschberg R, Benner D, Nissenson AR, Kopple JD. Understanding sources of dietary phosphorus in the treatment of patients with chronic kidney disease. Clin J Am Soc Nephrol. 2010 Mar;5(3):519-30. doi: 10.2215/CJN.06080809. Epub 2010 Jan 21.
- Background: PubMed 19064510Shinaberger CS, Greenland S, Kopple JD, Van Wyck D, Mehrotra R, Kovesdy CP, Kalantar-Zadeh K. Is controlling phosphorus by decreasing dietary protein intake beneficial or harmful in persons with chronic kidney disease? Am J Clin Nutr. 2008 Dec;88(6):1511-8. doi: 10.3945/ajcn.2008.26665.
- Background: PubMed 20404416Noori N, Sims JJ, Kopple JD, Shah A, Colman S, Shinaberger CS, Bross R, Mehrotra R, Kovesdy CP, Kalantar-Zadeh K. Organic and inorganic dietary phosphorus and its management in chronic kidney disease. Iran J Kidney Dis. 2010 Apr;4(2):89-100.
- Background: PubMed 18368510Kovesdy CP, Kalantar-Zadeh K. Bone and mineral disorders in pre-dialysis CKD. Int Urol Nephrol. 2008;40(2):427-40. doi: 10.1007/s11255-008-9346-7.
- Background: PubMed 16820797Kalantar-Zadeh K, Kuwae N, Regidor DL, Kovesdy CP, Kilpatrick RD, Shinaberger CS, McAllister CJ, Budoff MJ, Salusky IB, Kopple JD. Survival predictability of time-varying indicators of bone disease in maintenance hemodialysis patients. Kidney Int. 2006 Aug;70(4):771-80. doi: 10.1038/sj.ki.5001514. Epub 2006 Jul 5.
- Background: PubMed 16797385Shinaberger CS, Kilpatrick RD, Regidor DL, McAllister CJ, Greenland S, Kopple JD, Kalantar-Zadeh K. Longitudinal associations between dietary protein intake and survival in hemodialysis patients. Am J Kidney Dis. 2006 Jul;48(1):37-49. doi: 10.1053/j.ajkd.2006.03.049.
- Background: PubMed 18579668Mehrotra R, Martin KJ, Fishbane S, Sprague SM, Zeig S, Anger M; Fosrenol Overview Research Evaluation Study for Early Experience Study Group. Higher strength lanthanum carbonate provides serum phosphorus control with a low tablet burden and is preferred by patients and physicians: a multicenter study. Clin J Am Soc Nephrol. 2008 Sep;3(5):1437-45. doi: 10.2215/CJN.04741107. Epub 2008 Jun 25.
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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.
Kamyar Kalantar-Zadeh, MD, MPH, PhD principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A study of End-Stage Renal Disease, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
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 2 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 29 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
1. Change in serum albumin by +0.2 g/dl or higher over 2 months, i.e., from baseline (Month 0) to Month 2 (main outcome measure) (time frame: 2 months). 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 NCT01116947, which also lists 9 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 29 Feb 2012.