Chronic Kidney Disease(CKD)CKDNCT04579315
Long-term Effects of the New Nordic Renal Diet in Patients With Moderate Chronic Kidney Disease
A study testing Intervention group; NNRD group in people with Chronic Kidney Disease(CKD) and Hyperphosphatemia, run by Bo Feldt-Rasmussen at 1 site in Denmark.
Trial summary
As Chronic Kidney Disease (CKD) progresses normophosphatemia is maintained by increasing the per nephron urinary phosphorus excretion. Clinically, hyperphosphatemia is associated with high mortality, vascular calcification, endothelial dysfunction and progression of left ventricular hypertrophy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease(CKD), Hyperphosphatemia, Blood Pressure
- What is being tested?
- Intervention group; NNRD group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Nov 2020to 30 Nov 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18
- Estimated glomerular filtration rate (eGFR) 20-45 ml/min
- Medically stable for two months prior to study start
- Written and verbally information is given
- Read, speak and understands Danish
- Written consent
Who cannot join
- Treatment with phosphate binders
- Metabolic disorders that requires specific dietary regulation
- Treatment with chemotherapy within the past 6 months
- Pregnancy and breastfeeding
- Food allergies
- Vegans
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effects of the New Nordic Renal Diet on Phosphorus and Lipid Homeostasis in Patients With Chronic Kidney Disease, Stages 3 and 4 - A Randomized Controlled Trial
As Chronic Kidney Disease (CKD) progresses normophosphatemia is maintained by increasing the per nephron urinary phosphorus excretion. Clinically, hyperphosphatemia is associated with high mortality, vascular calcification, endothelial dysfunction and progression of left ventricular hypertrophy. Currently the treatment of hyperphosphatemia is first being initiated in stage 5 and consists of dietetic guidance to avoid dietary phosphate and treatment with oral phosphate binders. However, studies have shown important side effects to phosphate binders in terms of progression of vascular calcifications. Therefore, it might be beneficial to start the dietetic treatment with a reduction of dietary phosphate earlier in the disease stage.
The aim of this project is to develop a New Nordic Renal Diet (NNRD) for CKD patients' stage 3-4 and to examine the long-term effects in a period of 26-weeks. NNRD has a high content of vegetable foods, less animal products and more local food items with a lesser content of phosphorus.
Read the detailed description
This study is a randomized controlled trial performed at Department of Nephrology Rigshospitalet, Copenhagen Denmark. Sixty patients will be randomized to either 26 weeks on the NNRD (intervention) or 26 weeks on their habitual diet (control). The patients will be randomized by blinded drawing by lot. The study participants can leave the trial at any time during the study period, without any explanation. The investigator can at any time pull a patient out of the trial, if there is concern for the patient's safety or if there is a breach in terms of following the protocol. The principal investigator is required to document and report dropouts from the study.
The project group has entered a cooperation agreement with Danish chefs. The agreement involves that a team consisting of highly talented chefs will create the recipes for the intervention. The recipes will be created in close collaboration with the principal investigator who will use her expertise within Clinical Nutrition to combine the international nutrients guidelines and culinarian experiences. Moreover, the agreement holds that they will find the raw materials needed for the recipes and deliver them weekly to the patients' homes throughout the study period in packages containing the recipes and raw materials. There will be no financial costs for the patients. The patients in the intervention group are expected to follow the recipes five days of the week during the study period. The final two days of the week, the patients must plan their own meals. However, still following the recommended guidelines upon the NNRD whole food approach delivered from the principal investigator, who is a phd.-student and also a registered clinical dietitian and MSc in clinical nutrition (Nikita Misella Hansen).
Sample size calculation and statistical analysis:
The sample size calculation is based on results from previous studies performed by this study group. Within 6 months of participating in this study we expect a decrease in eGFR to be about 1 ml/min/1.73 m2. This will have no influence on the total amount of 24-h urine phosphorus excretion (primary endpoint), as CKD progresses normophosphatemia is maintained by increasing the per nephron urinary phosphorus excretion stimulated by an increase in FGF23 and PTH leading to progressively increasing plasma levels of FGF23 and SHP the "phospho-toxicity model hypothesis" to a compensation from PTH and FGF23. In a randomized controlled study with a type-1-error risk of 0.05 (alfa, two tailed) and a power of 80% (beta) with a standard deviation of 24-h urine phosphorus excretion of 200 mg and a minimum clinical relevant difference of 300 mg the study population is estimated to 21 in each group. In case of drop-outs we will include 30 participants in each group. Therefore, total number of patients to be included in this study is 60.
Timeline for the study:
- Baseline (day 0) Written consent will be obtained, randomization will be performed, and the following data will be registered:
- Patient history: Gender, age, disease history, current medical record, diagnoses
- Comorbidities - e.g. cardiovascular diseases, chronic obstructive lung disease, diabetes, hyperlipidemia, hypertension
- Smoking (years) and alcohol consumption (average per week)
- Blood- and urine samples
- DEXA-scan and Electrocardiogram (ECG)
- Blood pressure
- Weight, BMI, hip- and waist circumference
- Questionnaires regarding quality of life
- Dietary record
- Day 14 The patients will be asked to deliver a 24-hour urine sample for measuring phosphorus excretion. Furthermore, blood samples will be drawn
- Day 30, 60, 90, 120, 150 Every 4th week during the study period of 26 weeks (a total of 6 times) all patients will be evaluated at the Department of Nephrology, University Hospital, Copenhagen. During these first 5 visits the following data will be gathered:
- 24-h urine phosphorus excretion
- Blood samples
- Blood pressure
- Weight, hip- and waist circumference
- Once a week Once every week the principal investigator will offer all the patients a telephone meeting. Duration of the phone conversation will depend on individual needs, but up to 20 minutes per patient/week despite of allocation. The content of these conversations will evolve around dietary intake and overall general condition. The principal investigator is in close collaboration with the others in the research group who are all medical doctors and will discuss any clinical problem if needed.
- Day 180 (study completion) During the last day of the study period, the patients will be asked to meet at Rigshospitalet one more time. Data as on day 30, 60, 90, 120 and 150 will be gathered, moreover the following information will be obtained:
- DEXA-scan and ECG
- Weight, BMI, hip- and waist circumference
- Questionnaires regarding quality of life
- Dietary record
- Follow-up visit Three months after study completion there will be an end-of-trial visit with a 24-h urine collection and blood samples
- Being tested
- Intervention group; NNRD group
- Keywords
- Chronic kidney disease, CKD, Phosphorus, Nutritional intervention, New Nordic Diet
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group; NNRD groupOther
The intervention is a whole food approach, meaning that the participants in the intervention group receives all daily food elements that they should consume
| Study group | Role | What they receive |
|---|---|---|
| Intervention group, NNRD group | Active comparator | Main principles of the interventional whole food approach are:
* Maximum of 850 mg phosphorous/day
* Protein: 0.8 g/kg/day
* 80% vegetable products; 20% animal products
* Maximum of 5-7 g NaCl/day (table salt)
* Fresh raw products
* Seasonal oriented
* Fish: At least once a week
* Vegetarian: At least once a week
* Wide range of fruit and vegetables
* Easy to follow in daily practice
* Rich in flavors
* Sufficient content of micro- and macronutrients Receives: Other: Intervention group; NNRD group |
| Control group | No intervention | There is no intervention, patients are following their habitual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in change in 24-hour urine phosphorus excretion from baseline to week 26 between the two study groups
24-hour urine sample
Measured: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Secondary outcomes (12)
Difference in changes from baseline to week 26 between study groups in urinary excretion of calcium - creatinine, -urea and protein
24-hour urine sample
Measured: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Difference in changes from baseline to week 26 between study groups in blood lipids
Blood samples
Measured: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Difference in changes from baseline to week 26 between study groups in FGF23, Fractional excretion of phosphorus, P-phosphate, P-calcium, P-PTH, P-1,25OH2vitamin D3 and P-albumin
Blood samples
Measured: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Difference in changes from baseline to week 26 between study groups in glomerular filtration rate, as judged by P-creatinine
Blood samples
Measured: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Difference in changes from baseline to week 26 between study groups in weight
Weight changes in kilograms
Measured: Baseline, day: 30, 60, 90, 120, 150, 180 and three months after study completion
Difference in changes from baseline to week 26 between study groups in hip- and waist circumferences
Hip/waist circumferences in centimeters
Measured: Baseline, day: 30, 60, 90, 120, 150, 180 and three months after study completion
Difference in changes from baseline to week 26 between study groups in bone mineral density using DEXA scan (Dual-energy X-ray absorptiometry)
Body composition, focusing on bone mineral density using DEXA scan (Dual-energy X-ray absorptiometry)
Measured: Baseline and study completion (day 180)
Difference in changes from baseline to week 26 between study groups in blood pressure, both systolic and diastolic blood pressure
Blood pressure mm Hg (systolic and diastolic)
Measured: Baseline, day: 30, 60, 90, 120, 150, 180 and three months after study completion
Difference in changes from baseline to week 26 between study groups in quality of life
Scale EQ-5D-5L questionnaire. Low/high scores varies in terms of reflecting better or worse outcomes
Measured: Baseline and study completion (day 180)
Dietary satisfaction in the intervention group
5-likert scale questionnaire. Low/high scores varies in terms of reflecting better or worse outcomes
Measured: Day 30, 60, 90, 120, 150, 180
Difference in changes from baseline to week 26 between study groups in SuPAR and GDF15
Blood samples
Measured: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Difference in change in metabolic acidosis from baseline to week 26 between the two study groups
24-hour urine sample
Measured: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start30 Nov 2020
- Primary completion30 Aug 2022
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease(CKD)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms, one intervention group and one control group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bo Feldt-Rasmussen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bo Feldt-Rasmussen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bo Feldt-Rasmussen, Professor, Study chair, Department of Nephrology, Rigshospitalet, Copenhagen Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579315
- Sponsor's protocol ID
- H-20026376
- Acronym
- CKD
- Status last verified
- Apr 2024
- First submitted
- 1 Oct 2020
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to make IPD available
Publications
Misella Hansen N, Kamper AL, Rix M, Feldt-Rasmussen B, Leipziger J, Sorensen MV, Berg P, Astrup A, Salomo L. Health effects of the New Nordic Renal Diet in patients with stage 3 and 4 chronic kidney disease, compared with habitual diet: a randomized trial. Am J Clin Nutr. 2023 Nov;118(5):1042-1054. doi: 10.1016/j.ajcnut.2023.08.008. Epub 2023 Aug 19.
PubMed 37598748Hansen NM, Rix M, Kamper AL, Feldt-Rasmussen B, Christoffersen C, Astrup A, Salomo L. Study protocol: long-term effect of the New Nordic Renal Diet on phosphorus and lipid homeostasis in patients with chronic kidney disease, stages 3 and 4: a randomised controlled trial. BMJ Open. 2021 Aug 30;11(8):e045754. doi: 10.1136/bmjopen-2020-045754.
PubMed 34462278
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of the New Nordic Renal Diet on Phosphorus and Lipid Homeostasis in Patients With Chronic Kidney Disease, Stages 3 and 4 - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04579315
- Acronym / sponsor ID
- CKD / H-20026376
- Keywords
- Chronic kidney disease, CKD, Phosphorus, Nutritional intervention, New Nordic Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bo Feldt-RasmussenUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 8 Oct 2020 (actual)
- 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.
As Chronic Kidney Disease (CKD) progresses normophosphatemia is maintained by increasing the per nephron urinary phosphorus excretion. Clinically, hyperphosphatemia is associated with high mortality, vascular calcification, endothelial dysfunction and progression of left ventricular hypertrophy. Currently the treatment of hyperphosphatemia is first being initiated in stage 5 and consists of dietetic guidance to avoid dietary phosphate and treatment with oral phosphate binders. However, studies have shown important side effects to phosphate binders in terms of progression of vascular calcifications. Therefore, it might be beneficial to start the dietetic treatment with a reduction of dietary phosphate earlier in the disease stage.
The aim of this project is to develop a New Nordic Renal Diet (NNRD) for CKD patients' stage 3-4 and to examine the long-term effects in a period of 26-weeks. NNRD has a high content of vegetable foods, less animal products and more local food items with a lesser content of phosphorus.
Detailed description
This study is a randomized controlled trial performed at Department of Nephrology Rigshospitalet, Copenhagen Denmark. Sixty patients will be randomized to either 26 weeks on the NNRD (intervention) or 26 weeks on their habitual diet (control). The patients will be randomized by blinded drawing by lot. The study participants can leave the trial at any time during the study period, without any explanation. The investigator can at any time pull a patient out of the trial, if there is concern for the patient's safety or if there is a breach in terms of following the protocol. The principal investigator is required to document and report dropouts from the study.
The project group has entered a cooperation agreement with Danish chefs. The agreement involves that a team consisting of highly talented chefs will create the recipes for the intervention. The recipes will be created in close collaboration with the principal investigator who will use her expertise within Clinical Nutrition to combine the international nutrients guidelines and culinarian experiences. Moreover, the agreement holds that they will find the raw materials needed for the recipes and deliver them weekly to the patients' homes throughout the study period in packages containing the recipes and raw materials. There will be no financial costs for the patients. The patients in the intervention group are expected to follow the recipes five days of the week during the study period. The final two days of the week, the patients must plan their own meals. However, still following the recommended guidelines upon the NNRD whole food approach delivered from the principal investigator, who is a phd.-student and also a registered clinical dietitian and MSc in clinical nutrition (Nikita Misella Hansen).
Sample size calculation and statistical analysis:
The sample size calculation is based on results from previous studies performed by this study group. Within 6 months of participating in this study we expect a decrease in eGFR to be about 1 ml/min/1.73 m2. This will have no influence on the total amount of 24-h urine phosphorus excretion (primary endpoint), as CKD progresses normophosphatemia is maintained by increasing the per nephron urinary phosphorus excretion stimulated by an increase in FGF23 and PTH leading to progressively increasing plasma levels of FGF23 and SHP the "phospho-toxicity model hypothesis" to a compensation from PTH and FGF23. In a randomized controlled study with a type-1-error risk of 0.05 (alfa, two tailed) and a power of 80% (beta) with a standard deviation of 24-h urine phosphorus excretion of 200 mg and a minimum clinical relevant difference of 300 mg the study population is estimated to 21 in each group. In case of drop-outs we will include 30 participants in each group. Therefore, total number of patients to be included in this study is 60.
Timeline for the study:
- Baseline (day 0) Written consent will be obtained, randomization will be performed, and the following data will be registered:
- Patient history: Gender, age, disease history, current medical record, diagnoses
- Comorbidities - e.g. cardiovascular diseases, chronic obstructive lung disease, diabetes, hyperlipidemia, hypertension
- Smoking (years) and alcohol consumption (average per week)
- Blood- and urine samples
- DEXA-scan and Electrocardiogram (ECG)
- Blood pressure
- Weight, BMI, hip- and waist circumference
- Questionnaires regarding quality of life
- Dietary record
- Day 14 The patients will be asked to deliver a 24-hour urine sample for measuring phosphorus excretion. Furthermore, blood samples will be drawn
- Day 30, 60, 90, 120, 150 Every 4th week during the study period of 26 weeks (a total of 6 times) all patients will be evaluated at the Department of Nephrology, University Hospital, Copenhagen. During these first 5 visits the following data will be gathered:
- 24-h urine phosphorus excretion
- Blood samples
- Blood pressure
- Weight, hip- and waist circumference
- Once a week Once every week the principal investigator will offer all the patients a telephone meeting. Duration of the phone conversation will depend on individual needs, but up to 20 minutes per patient/week despite of allocation. The content of these conversations will evolve around dietary intake and overall general condition. The principal investigator is in close collaboration with the others in the research group who are all medical doctors and will discuss any clinical problem if needed.
- Day 180 (study completion) During the last day of the study period, the patients will be asked to meet at Rigshospitalet one more time. Data as on day 30, 60, 90, 120 and 150 will be gathered, moreover the following information will be obtained:
- DEXA-scan and ECG
- Weight, BMI, hip- and waist circumference
- Questionnaires regarding quality of life
- Dietary record
- Follow-up visit Three months after study completion there will be an end-of-trial visit with a 24-h urine collection and blood samples
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arms, one intervention group and one control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group, NNRD group | Active comparator | Other: Intervention group; NNRD groupMain principles of the interventional whole food approach are: * Maximum of 850 mg phosphorous/day * Protein: 0.8 g/kg/day * 80% vegetable products; 20% animal products * Maximum of 5-7 g NaCl/day (table salt) * Fresh raw products * Seasonal oriented * Fish: At least once a week * Vegetarian: At least once a week * Wide range of fruit and vegetables * Easy to follow in daily practice * Rich in flavors * Sufficient content of micro- and macronutrients |
| Control group | No intervention | –There is no intervention, patients are following their habitual diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18
- Estimated glomerular filtration rate (eGFR) 20-45 ml/min
- Medically stable for two months prior to study start
- Written and verbally information is given
- Read, speak and understands Danish
Key exclusion criteria (6 listed)
- Treatment with phosphate binders
- Metabolic disorders that requires specific dietary regulation
- Treatment with chemotherapy within the past 6 months
- Pregnancy and breastfeeding
- Food allergies
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 |
|---|---|---|
| Intervention group; NNRD groupThe intervention is a whole food approach, meaning that the participants in the intervention group receives all daily food elements that they should consume | Other | Intervention group, NNRD group |
Primary outcome
Difference in change in 24-hour urine phosphorus excretion from baseline to week 26 between the two study groups
Time frame: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
24-hour urine sample
12 secondary outcomes
Difference in changes from baseline to week 26 between study groups in urinary excretion of calcium - creatinine, -urea and protein
Time frame: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Difference in changes from baseline to week 26 between study groups in blood lipids
Time frame: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Difference in changes from baseline to week 26 between study groups in FGF23, Fractional excretion of phosphorus, P-phosphate, P-calcium, P-PTH, P-1,25OH2vitamin D3 and P-albumin
Time frame: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Difference in changes from baseline to week 26 between study groups in glomerular filtration rate, as judged by P-creatinine
Time frame: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Difference in changes from baseline to week 26 between study groups in weight
Time frame: Baseline, day: 30, 60, 90, 120, 150, 180 and three months after study completion
Difference in changes from baseline to week 26 between study groups in hip- and waist circumferences
Time frame: Baseline, day: 30, 60, 90, 120, 150, 180 and three months after study completion
Difference in changes from baseline to week 26 between study groups in bone mineral density using DEXA scan (Dual-energy X-ray absorptiometry)
Time frame: Baseline and study completion (day 180)
Difference in changes from baseline to week 26 between study groups in blood pressure, both systolic and diastolic blood pressure
Time frame: Baseline, day: 30, 60, 90, 120, 150, 180 and three months after study completion
Difference in changes from baseline to week 26 between study groups in quality of life
Time frame: Baseline and study completion (day 180)
Dietary satisfaction in the intervention group
Time frame: Day 30, 60, 90, 120, 150, 180
Difference in changes from baseline to week 26 between study groups in SuPAR and GDF15
Time frame: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
Difference in change in metabolic acidosis from baseline to week 26 between the two study groups
Time frame: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion
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 12 Apr 2024.
- Derived from this study: PubMed 37598748Misella Hansen N, Kamper AL, Rix M, Feldt-Rasmussen B, Leipziger J, Sorensen MV, Berg P, Astrup A, Salomo L. Health effects of the New Nordic Renal Diet in patients with stage 3 and 4 chronic kidney disease, compared with habitual diet: a randomized trial. Am J Clin Nutr. 2023 Nov;118(5):1042-1054. doi: 10.1016/j.ajcnut.2023.08.008. Epub 2023 Aug 19.
- Derived from this study: PubMed 34462278Hansen NM, Rix M, Kamper AL, Feldt-Rasmussen B, Christoffersen C, Astrup A, Salomo L. Study protocol: long-term effect of the New Nordic Renal Diet on phosphorus and lipid homeostasis in patients with chronic kidney disease, stages 3 and 4: a randomised controlled trial. BMJ Open. 2021 Aug 30;11(8):e045754. doi: 10.1136/bmjopen-2020-045754.
- Individual participant dataSharing planned: No. There is no current plan to make IPD available
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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.
Bo Feldt-Rasmussen, Professor study chair
Department of Nephrology, Rigshospitalet, Copenhagen Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group; NNRD group in people with Chronic Kidney Disease(CKD) and Hyperphosphatemia, run by Bo Feldt-Rasmussen at 1 site in Denmark.
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 6 inclusion and 6 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 12 Apr 2024. 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 Denmark. 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.
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?
Difference in change in 24-hour urine phosphorus excretion from baseline to week 26 between the two study groups (time frame: Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion). 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 NCT04579315, which also lists 2 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 12 Apr 2024.