HypertensionSPLIDNCT05041829
Dietary Sodium Intake and Blood Pressure in Living Kidney Donors
A study testing Dietary sodium in people with Hypertension and Living Kidney Donor, run by University of California, Irvine at 1 site in United States.
Trial summary
This is a pilot study to determine the feasibility of the study design and examine the main outcome whether low dietary sodium intake is superior to high dietary sodium intake in controlling blood pressure to be within the normotensive range in living kidney donors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Living Kidney Donor, Dietary Sodium Intake
- What is being tested?
- Dietary sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2021to 30 Jun 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Living kidney donors who underwent a living kidney donation at least 5 months ago but not more than 12 months
- Age ≥18 years old
- Agree to perform the procedure as per study protocol (Table 1)
- Living kidney donors with an average sitting SBP <160 mmHg at 5-month post-donation measured by automatic office blood pressure (AOBP)
- Able to sign informed consent
- Able to attend all research visits
- Woman using birth control methods other than hormonal contraception
Who cannot join
- History of previous cardiovascular (CV) events including acute MI, HF, and stroke
- Symptomatic heart failure within 5 months after living kidney donation or left ventricular ejection fraction (by any method) <35%
- CV event or procedure or hospitalization for hypertensive-related disorders within 5 months after living kidney donation
- Diagnosed with HTN or on antihypertensive medication(s) before living kidney donation
- Patients who are supposed to take BP lowering medications for reasons other than BP control but do not take those medications or take them with in appropriate doses
- Arm circumference is too small or large to allow accurate BP measurement with available 24-h ABPM machines.
Show all 30Show fewer
- An average standing SBP ≥160 mmHg at 5-month post-donation measured by automatic office blood pressure (AOBP)
- Albuminuria that equals or is equivalent to 1 g per day by using spot urinary albumin per urine creatinine ratio (UACR) or 24-hour urinary albumin excretion rate by a 24-hour urine collection within 5 months post-donation
- Advanced kidney function defined by estimated glomerular filtration rate (eGFR) by using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation22 of <20 ml/min/1.73m2 or requiring dialysis after living kidney donation
- Drink coffee > two 8-ounce (237 mL) cup a day or equivalence
- Drinks alcohol >3 drinks/day or >30 ml/day
- Smoking cigarette ≥10 cigarettes/day
- Take Nonsteroidal anti-inflammatory drugs (NSAIDS)
- Use hormone replacement therapy or oral contraceptives
- Pregnancy, currently trying to become pregnant
- Using birth control pills
- A medical condition likely to limit survival to less than 2 years
- Any factors that are likely to limit adherence to interventions. For example,
- Living kidney donors who cannot come to follow up regularly per study protocol to logistically collect data from enrolled participants.
- Active alcohol or substance abuse within the last 5 months of living kidney donation
- Plans to move outside the clinic catchment area in the next 4 months without the ability to transfer to come to follow up at SPLID study site.
- Significant history of poor adherences with medications or attendance at clinic visits
- Significant concerns about participation in the study from spouse, significant other, or family members
- Lack of support from primary health care provider
- Residence too far from the study clinic site such that transportation is a barrier including persons who require transportation assistance provided by the SPLID clinic funds for screening or randomization visits
- Residence in a nursing home or an assisted living
- Clinical dementia with or without treatment with medications and cognitively unable to follow the protocol
- Other medical, psychiatric, or behavioral factors that may interfere with study participation or the ability to follow the intervention protocol
- Inability to obtain informed consent from participant
- Living in the same household as an already randomized SPLID participant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Irvine Medical Center
Orange, California, 92868
About this study
Official title: Dietary Sodium Intake and Blood Pressure in Living Kidney Donors: A Pilot Single-Center Crossover Single-Blind Randomized Controlled Trial
This is a pilot study to determine the feasibility of the study design and examine the main outcome whether low dietary sodium intake is superior to high dietary sodium intake in controlling blood pressure to be within the normotensive range in living kidney donors.
Read the detailed description
This is a pilot study to determine the feasibility of the study design and examine the main outcome whether low dietary sodium intake <2.3 g/day (<100 mmol/day) is superior to high dietary sodium intake ≥4 - <6 g/day (≥174 - <261 mmo/day) in controlling blood pressure (BP) to be within normotensive range, lowering systolic and diastolic blood pressures (SBP and DBP) from the baseline blood pressures, and decreasing the risk of hypertension, worsening kidney function, and proteinuria in living kidney donors between 5 and 12 months after living kidney donation?.
- Conditions
- Hypertension, Living Kidney Donor, Dietary Sodium Intake
- Being tested
- Dietary sodium
- Keywords
- Living kidney donor, High blood pressure, Salt intake, Clinical trial
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary sodiumOther
Low sodium diet with sodium of <2.3 g/day (<100 mmol/day) and high sodium diet with sodium of ≥4 - <6 g/day (≥174 - <261 mmo/day)
| Study group | Role | What they receive |
|---|---|---|
| lowsodium | Experimental | Participants in this arm will be guided to have low dietary sodium intake of <2.3 g/day (<100 mmol/day) for 4 weeks. Receives: Other: Dietary sodium |
| highsodium | Active comparator | Participants in this arm will be guided to have low dietary sodium intake of ≥4 - <6 g/day (≥174 - <261 mmo/day) for 4 weeks. Receives: Other: Dietary sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic and diastolic blood pressure from baseline to post-treatment between the two treatment groups
Change in systolic and diastolic blood pressure from baseline to post-treatment between the two treatment groups, adjusting for patients' demographic and clinical differences (age, gender, BMI, and comorbidities) between the two treatment groups
Measured: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Secondary outcomes (4)
Hypertension
New-onset hypertension defined as systolic blood pressure >/= 130 or diastolic blood pressure >/=80 mmHg
Measured: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Worsening kidney function
Increased estimated glomerular filtration rate (eGFR) >/= 25 ml/min/1.73 m2 or increased serum creatinine >/= 0.3 mg/dL
Measured: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Worsening proteinuria
Increase in urinary albumin excretion rate (AER) ≥30 mg/day
Measured: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Proteinuria
New-onset urinary albumin excretion rate (AER) ≥30 mg/day
Measured: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start3 Nov 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Why it stopped: Waiting for IRB approval for IRB renewal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- There are two 4-week experimental periods, each participant will received low and high sodium diet during one of the periods and the order of the amount of sodium diet will be determined by randomization.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekamol Tantisattamo, MD, MPH, University of California, Irvine
- Investigators
- Ekamol Tantisattamo, MD, MPH, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041829
- Sponsor's protocol ID
- 20216478
- Acronym
- SPLID
- Status last verified
- Aug 2025
- First submitted
- 3 Sep 2021
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
PubMed 23303884Suthanthiran M, Strom TB. Renal transplantation. N Engl J Med. 1994 Aug 11;331(6):365-76. doi: 10.1056/NEJM199408113310606. No abstract available.
PubMed 7832839Subramanian L, Kirk R, Cuttitta T, Bryant N, Fox K, McCall M, Perry E, Swartz J, Restovic Y, Jeter A, Bernardo A, Robinson B, Perl J, Pisoni R, Perlman RL. Remote Management for Peritoneal Dialysis: A Qualitative Study of Patient, Care Partner, and Clinician Perceptions and Priorities in the United States and the United Kingdom. Kidney Med. 2019 Oct 17;1(6):354-365. doi: 10.1016/j.xkme.2019.07.014. eCollection 2019 Nov-Dec.
PubMed 32734216Davis CL, Delmonico FL. Living-donor kidney transplantation: a review of the current practices for the live donor. J Am Soc Nephrol. 2005 Jul;16(7):2098-110. doi: 10.1681/ASN.2004100824. Epub 2005 Jun 1.
PubMed 15930096Hart A, Smith JM, Skeans MA, Gustafson SK, Wilk AR, Castro S, Foutz J, Wainright JL, Snyder JJ, Kasiske BL, Israni AK. OPTN/SRTR 2018 Annual Data Report: Kidney. Am J Transplant. 2020 Jan;20 Suppl s1:20-130. doi: 10.1111/ajt.15672.
PubMed 31898417Lentine KL, Lam NN, Axelrod D, Schnitzler MA, Garg AX, Xiao H, Dzebisashvili N, Schold JD, Brennan DC, Randall H, King EA, Segev DL. Perioperative Complications After Living Kidney Donation: A National Study. Am J Transplant. 2016 Jun;16(6):1848-57. doi: 10.1111/ajt.13687. Epub 2016 Mar 10.
PubMed 26700551Lentine KL, Lam NN, Segev DL. Risks of Living Kidney Donation: Current State of Knowledge on Outcomes Important to Donors. Clin J Am Soc Nephrol. 2019 Apr 5;14(4):597-608. doi: 10.2215/CJN.11220918. Epub 2019 Mar 11.
PubMed 30858158Tantisattamo E, Dafoe DC, Reddy UG, Ichii H, Rhee CM, Streja E, Landman J, Kalantar-Zadeh K. Current Management of Patients With Acquired Solitary Kidney. Kidney Int Rep. 2019 Jul 11;4(9):1205-1218. doi: 10.1016/j.ekir.2019.07.001. eCollection 2019 Sep.
PubMed 31517140Holscher CM, Haugen CE, Jackson KR, Garonzik Wang JM, Waldram MM, Bae S, Locke JE, Reed RD, Lentine KL, Gupta G, Weir MR, Friedewald JJ, Verbesey J, Cooper M, Segev DL, Massie AB. Self-Reported Incident Hypertension and Long-Term Kidney Function in Living Kidney Donors Compared with Healthy Nondonors. Clin J Am Soc Nephrol. 2019 Oct 7;14(10):1493-1499. doi: 10.2215/CJN.04020419. Epub 2019 Sep 19.
PubMed 31537534Davis CL, Cooper M. The state of U.S. living kidney donors. Clin J Am Soc Nephrol. 2010 Oct;5(10):1873-80. doi: 10.2215/CJN.01510210. Epub 2010 Jul 15.
PubMed 20634322Boudville N, Prasad GV, Knoll G, Muirhead N, Thiessen-Philbrook H, Yang RC, Rosas-Arellano MP, Housawi A, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. Meta-analysis: risk for hypertension in living kidney donors. Ann Intern Med. 2006 Aug 1;145(3):185-96. doi: 10.7326/0003-4819-145-3-200608010-00006.
PubMed 16880460Lentine KL, Kasiske BL, Levey AS, Adams PL, Alberu J, Bakr MA, Gallon L, Garvey CA, Guleria S, Li PK, Segev DL, Taler SJ, Tanabe K, Wright L, Zeier MG, Cheung M, Garg AX. KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors. Transplantation. 2017 Aug;101(8S Suppl 1):S1-S109. doi: 10.1097/TP.0000000000001769.
PubMed 28742762Svetkey LP, Sacks FM, Obarzanek E, Vollmer WM, Appel LJ, Lin PH, Karanja NM, Harsha DW, Bray GA, Aickin M, Proschan MA, Windhauser MM, Swain JF, McCarron PB, Rhodes DG, Laws RL. The DASH Diet, Sodium Intake and Blood Pressure Trial (DASH-sodium): rationale and design. DASH-Sodium Collaborative Research Group. J Am Diet Assoc. 1999 Aug;99(8 Suppl):S96-104. doi: 10.1016/s0002-8223(99)00423-x.
PubMed 10450301Gay HC, Rao SG, Vaccarino V, Ali MK. Effects of Different Dietary Interventions on Blood Pressure: Systematic Review and Meta-Analysis of Randomized Controlled Trials. Hypertension. 2016 Apr;67(4):733-9. doi: 10.1161/HYPERTENSIONAHA.115.06853. Epub 2016 Feb 22.
PubMed 26902492Yoon CY, Noh J, Lee J, Kee YK, Seo C, Lee M, Cha MU, Kim H, Park S, Yun HR, Jung SY, Jhee JH, Han SH, Yoo TH, Kang SW, Park JT. High and low sodium intakes are associated with incident chronic kidney disease in patients with normal renal function and hypertension. Kidney Int. 2018 Apr;93(4):921-931. doi: 10.1016/j.kint.2017.09.016. Epub 2017 Dec 1.
PubMed 29198468
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Sodium Intake and Blood Pressure in Living Kidney Donors: A Pilot Single-Center Crossover Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05041829
- Acronym / sponsor ID
- SPLID / 20216478
- Conditions
- Hypertension, Living Kidney Donor, Dietary Sodium Intake
- Keywords
- Living kidney donor, High blood pressure, Salt intake, Clinical trial
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Waiting for IRB approval for IRB renewal
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 13 Sep 2021 (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.
This is a pilot study to determine the feasibility of the study design and examine the main outcome whether low dietary sodium intake is superior to high dietary sodium intake in controlling blood pressure to be within the normotensive range in living kidney donors.
Detailed description
This is a pilot study to determine the feasibility of the study design and examine the main outcome whether low dietary sodium intake <2.3 g/day (<100 mmol/day) is superior to high dietary sodium intake ≥4 - <6 g/day (≥174 - <261 mmo/day) in controlling blood pressure (BP) to be within normotensive range, lowering systolic and diastolic blood pressures (SBP and DBP) from the baseline blood pressures, and decreasing the risk of hypertension, worsening kidney function, and proteinuria in living kidney donors between 5 and 12 months after living kidney donation?.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- There are two 4-week experimental periods, each participant will received low and high sodium diet during one of the periods and the order of the amount of sodium diet will be determined by randomization.
| Arm | Type | Receives |
|---|---|---|
| lowsodium | Experimental | Other: Dietary sodiumParticipants in this arm will be guided to have low dietary sodium intake of <2.3 g/day (<100 mmol/day) for 4 weeks. |
| highsodium | Active comparator | Other: Dietary sodiumParticipants in this arm will be guided to have low dietary sodium intake of ≥4 - <6 g/day (≥174 - <261 mmo/day) for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Living kidney donors who underwent a living kidney donation at least 5 months ago but not more than 12 months
- Age ≥18 years old
- Agree to perform the procedure as per study protocol (Table 1)
- Living kidney donors with an average sitting SBP <160 mmHg at 5-month post-donation measured by automatic office blood pressure (AOBP)
- Able to sign informed consent
Key exclusion criteria (30 listed)
- History of previous cardiovascular (CV) events including acute MI, HF, and stroke
- Symptomatic heart failure within 5 months after living kidney donation or left ventricular ejection fraction (by any method) <35%
- CV event or procedure or hospitalization for hypertensive-related disorders within 5 months after living kidney donation
- Diagnosed with HTN or on antihypertensive medication(s) before living kidney donation
- Patients who are supposed to take BP lowering medications for reasons other than BP control but do not take those medications or take them with in appropriate doses
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 |
|---|---|---|
| Dietary sodiumLow sodium diet with sodium of <2.3 g/day (<100 mmol/day) and high sodium diet with sodium of ≥4 - <6 g/day (≥174 - <261 mmo/day) | Other | highsodium, lowsodium |
Primary outcome
Change in systolic and diastolic blood pressure from baseline to post-treatment between the two treatment groups
Time frame: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Change in systolic and diastolic blood pressure from baseline to post-treatment between the two treatment groups, adjusting for patients' demographic and clinical differences (age, gender, BMI, and comorbidities) between the two treatment groups
4 secondary outcomes
Hypertension
Time frame: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Worsening kidney function
Time frame: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Worsening proteinuria
Time frame: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Proteinuria
Time frame: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Results publication: PubMed 23303884Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
- Results publication: PubMed 7832839Suthanthiran M, Strom TB. Renal transplantation. N Engl J Med. 1994 Aug 11;331(6):365-76. doi: 10.1056/NEJM199408113310606. No abstract available.
- Results publication: PubMed 32734216Subramanian L, Kirk R, Cuttitta T, Bryant N, Fox K, McCall M, Perry E, Swartz J, Restovic Y, Jeter A, Bernardo A, Robinson B, Perl J, Pisoni R, Perlman RL. Remote Management for Peritoneal Dialysis: A Qualitative Study of Patient, Care Partner, and Clinician Perceptions and Priorities in the United States and the United Kingdom. Kidney Med. 2019 Oct 17;1(6):354-365. doi: 10.1016/j.xkme.2019.07.014. eCollection 2019 Nov-Dec.
- Results publication: PubMed 15930096Davis CL, Delmonico FL. Living-donor kidney transplantation: a review of the current practices for the live donor. J Am Soc Nephrol. 2005 Jul;16(7):2098-110. doi: 10.1681/ASN.2004100824. Epub 2005 Jun 1.
- Results publication: PubMed 31898417Hart A, Smith JM, Skeans MA, Gustafson SK, Wilk AR, Castro S, Foutz J, Wainright JL, Snyder JJ, Kasiske BL, Israni AK. OPTN/SRTR 2018 Annual Data Report: Kidney. Am J Transplant. 2020 Jan;20 Suppl s1:20-130. doi: 10.1111/ajt.15672.
- Results publication: PubMed 26700551Lentine KL, Lam NN, Axelrod D, Schnitzler MA, Garg AX, Xiao H, Dzebisashvili N, Schold JD, Brennan DC, Randall H, King EA, Segev DL. Perioperative Complications After Living Kidney Donation: A National Study. Am J Transplant. 2016 Jun;16(6):1848-57. doi: 10.1111/ajt.13687. Epub 2016 Mar 10.
- Results publication: PubMed 30858158Lentine KL, Lam NN, Segev DL. Risks of Living Kidney Donation: Current State of Knowledge on Outcomes Important to Donors. Clin J Am Soc Nephrol. 2019 Apr 5;14(4):597-608. doi: 10.2215/CJN.11220918. Epub 2019 Mar 11.
- Results publication: PubMed 31517140Tantisattamo E, Dafoe DC, Reddy UG, Ichii H, Rhee CM, Streja E, Landman J, Kalantar-Zadeh K. Current Management of Patients With Acquired Solitary Kidney. Kidney Int Rep. 2019 Jul 11;4(9):1205-1218. doi: 10.1016/j.ekir.2019.07.001. eCollection 2019 Sep.
- Results publication: PubMed 31537534Holscher CM, Haugen CE, Jackson KR, Garonzik Wang JM, Waldram MM, Bae S, Locke JE, Reed RD, Lentine KL, Gupta G, Weir MR, Friedewald JJ, Verbesey J, Cooper M, Segev DL, Massie AB. Self-Reported Incident Hypertension and Long-Term Kidney Function in Living Kidney Donors Compared with Healthy Nondonors. Clin J Am Soc Nephrol. 2019 Oct 7;14(10):1493-1499. doi: 10.2215/CJN.04020419. Epub 2019 Sep 19.
- Results publication: PubMed 20634322Davis CL, Cooper M. The state of U.S. living kidney donors. Clin J Am Soc Nephrol. 2010 Oct;5(10):1873-80. doi: 10.2215/CJN.01510210. Epub 2010 Jul 15.
- Results publication: PubMed 16880460Boudville N, Prasad GV, Knoll G, Muirhead N, Thiessen-Philbrook H, Yang RC, Rosas-Arellano MP, Housawi A, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. Meta-analysis: risk for hypertension in living kidney donors. Ann Intern Med. 2006 Aug 1;145(3):185-96. doi: 10.7326/0003-4819-145-3-200608010-00006.
- Results publication: PubMed 28742762Lentine KL, Kasiske BL, Levey AS, Adams PL, Alberu J, Bakr MA, Gallon L, Garvey CA, Guleria S, Li PK, Segev DL, Taler SJ, Tanabe K, Wright L, Zeier MG, Cheung M, Garg AX. KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors. Transplantation. 2017 Aug;101(8S Suppl 1):S1-S109. doi: 10.1097/TP.0000000000001769.
- Individual participant dataSharing planned: Undecided
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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.
Ekamol Tantisattamo, MD, MPH principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary sodium in people with Hypertension and Living Kidney Donor, run by University of California, Irvine 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 7 inclusion and 30 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: paused, as of the sponsor's last update on 21 Aug 2025. 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.
Are results available for this study?
Results are not available in the source record.
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?
Change in systolic and diastolic blood pressure from baseline to post-treatment between the two treatment groups (time frame: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover). 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 NCT05041829, which also lists 27 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 21 Aug 2025.