Autosomal Dominant Polycystic Kidney DiseasePhase 2RAFALENCT01932450
Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control
A Phase 2 study testing renal sympathetic denervation and antihypertensive drugs in people with Autosomal Dominant Polycystic Kidney Disease and Hypertension, run by Mei changlin at 1 site in China.
Trial summary
A randomized, open-label single-center study investigates the efficacy and safety of bilateral renal artery sympathetic denervation by catheter-based radiofrequency ablation on blood pressure and disease progression control in autosomal dominant polycystic kidney disease(ADPKD). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease, Hypertension
- What is being tested?
- renal sympathetic denervation and antihypertensive drugs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Jul 2015
- Phase
- Phase 2
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with ADPKD.
- Having hypertension, defined as systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg, and currently using 2 antihypertensive drugs and receiving a stable antihypertensive treatment regimen without change in dose or medication in the previous 30 days.
- Male and female patients 20 years to 60 years of age.
- Glomerular Filtration Rate (GFR) ≥30 ml/min/1.73 m2, estimated from serum creatinine using the Chronic Kidney Disease Epidemiology collaboration(CKD-EPI) equation.
- Have followed-up kidney and cyst volume at least 6 months in Shanghai Changzheng Hospital.
- Signed Informed Consent after being informed.
Who cannot join
- Documented renal vascular disease.
- Congenital absence of a kidney.
- Systemic illness with renal involvement.
- Spot urine albumin-to-creatinine ratio of >0.5 g/g and/or findings suggestive of kidney disease other than ADPKD.
- Exclusions specific to MRI acquisition and measurement: cardiac pacemaker, presence of MRI incompatible metallic clips or other material, excessive body weight, untreatable claustrophobia.
- Contraindications to the catheter-based renal denervation procedure by RFA, including allergy to radioiodinated contrast agents. Anatomical abnormalities of the renal arteries which preclude RFA: presence in either kidneys of multiple main renal arteries, main renal artery stenosis >50%, or main renal arteries of <4 mm in diameter or <20 mm in length.
Show all 16Show fewer
- Contraindications on ethical grounds.
- Women who are pregnant or breast feeding.
- Intention to become pregnant during the course of the study.
- Lack of safe contraception: Female subjects of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases (Female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential).
- Other clinically significant concomitant disease states (hepatic dysfunction, cardiovascular disease, metastatic cancer).
- Known or suspected non-compliance, drug or alcohol abuse.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject.
- Participation in another study with investigational drug within the 30 days preceding and during the present study.
- Previous enrolment into the current study.
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nephrology, Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Changlin Mei, MD, +862181885391, chlmei1954@126.com
Yiyi Ma, Master, +8613661679863, dukemm@126.com
About this study
Official title: A Randomized, Open-label Study Investigating the Effect of Bilateral Renal Artery Sympathetic Denervation by Catheter-based Radiofrequency Ablation on Blood Pressure and Disease Progression in Autosomal Dominant Polycystic Kidney Disease
A randomized, open-label single-center study investigates the efficacy and safety of bilateral renal artery sympathetic denervation by catheter-based radiofrequency ablation on blood pressure and disease progression control in autosomal dominant polycystic kidney disease(ADPKD). The total number of study subjects will be 100. All of them have diagnosed with ADPKD and hypertension. Patients will be randomized 1:1 (50 with radiofrequency ablation(RFA), 50 only with drugs). Change in average office-based measurements of systolic blood pressure(SBP), average 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) , incidence of office systolic blood pressure reductions of ≥10, ≥15 and ≥20 mm Hg , office diastolic blood pressure (DBP), number and dosage of blood pressure tablets, total kidney volume (TKV), total cyst volume (TCV), pain related to cystic kidneys and renal function, will be assessed at 12 months of follow-up. The safety variables will be assessed at every visit of follow-up.
- Being tested
- renal sympathetic denervation, antihypertensive drugs
- Keywords
- hypertension, radiofrequency ablation, autosomal dominant polycystic kidney disease
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal sympathetic denervationProcedure or surgery
Also called Percutaneous radiofrequency ablation of renal nerves, Transcatheter renal denervation, renal denervation, renal ablation
One-time standard Catheter-based renal sympathetic denervation will be performed in both renal arteries by radiofrequency ablation.
antihypertensive drugsDrug
antihypertensive drugs have been used from baseline in patients, and will be modified by patient's blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| renal sympathetic denervation | Experimental | One-time standard bilateral renal sympathetic denervation by catheter-based radiofrequency ablation and using antihypertensive drugs which at least include an angiotensin converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB). Receives: Procedure: renal sympathetic denervation; Drug: antihypertensive drugs |
| antihypertensive drugs | Active comparator | Blood pressure control in ADPKD patients with hypertension only using antihypertensive drugs which at least include an angiotensin converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB) Receives: Drug: antihypertensive drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
office-based measurements of systolic blood pressure
Between-group change in average office-based measurements of systolic blood pressure from baseline to 12 months after randomization and One-time standard bilateral renal sympathetic denervation by catheter-based radiofrequency ablation.
Measured: baseline and 12 months (day 360±14)
Secondary outcomes (16)
24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM)
Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) from baseline to 12 month.
Measured: baseline and 12 months (day 360±14)
Incidence of office systolic blood pressure reduction
Incidence of office systolic blood pressure reductions of ≥10, ≥15 and ≥20 mm Hg from baseline to 12 month.
Measured: baseline and 12 months (day 360±14)
office diastolic blood pressure
Change in office diastolic blood pressure from baseline to 12 months.
Measured: baseline and 12 months (day 360±14)
number and dosage of blood pressure tablets
Change in number and dosage of blood pressure tablets from baseline to 12 months.
Measured: baseline and 12 months (day 360±14)
estimated Glomerular Filtration Rate(eGFR)
Change in estimated Glomerular Filtration Rate(eGFR) from baseline to 12 months.
Measured: baseline and 12 months (day 360±14)
albuminuria
Change in albuminuria from baseline to 12 months.
Measured: baseline and 12 months (day 360±14)
total kidney volume (TKV)
Change in total kidney volume (TKV) from baseline to 12 months
Measured: baseline and 12 months (day 360±14)
pain
Change in pain related to cystic kidneys from baseline to 12 months.
Measured: baseline and 12 months (day 360±14)
procedure-related complications at femoral puncture site
Occurrence of procedure-related complications at femoral puncture site (hematoma, arteriovenous fistula, pseudoaneurysma).
Measured: up to 1 year (after radiofrequency ablation)
Renal artery lesion
Renal artery lesion (perforation or dissection).
Measured: up to 1 year (after radiofrequency ablation)
New renal artery stenosis
New renal artery stenosis >70%, determined by MRI within 12 months of randomization.
Measured: up to 1 year (after radiofrequency ablation)
Embolic events
Embolic events.
Measured: up to 1 year (after radiofrequency ablation)
hypotension
Episodes of hypotension.
Measured: up to 1 year (after radiofrequency ablation)
hypertension.
Episodes of hypertension.
Measured: up to 1 year (after radiofrequency ablation)
acute kidney injury
Acute deterioration of renal function
Measured: up to 1 year (after radiofrequency ablation)
total cyst volume (TCV)
Change in total cyst volume (TCV) from baseline to 12 months
Measured: baseline and 12 months (day 360±14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Autosomal Dominant Polycystic Kidney 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mei changlin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mei changlin, Shanghai Changzheng Hospital
- Investigators
- Changlin Mei, MD, Principal investigator, Nephrology Department of Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932450
- Sponsor's protocol ID
- CZKIPLA-ADPKD-001
- Acronym
- RAFALE
- Status last verified
- Sep 2014
- First submitted
- 18 Aug 2013
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Torres VE, Harris PC, Pirson Y. Autosomal dominant polycystic kidney disease. Lancet. 2007 Apr 14;369(9569):1287-1301. doi: 10.1016/S0140-6736(07)60601-1.
PubMed 17434405Harris PC, Torres VE. Polycystic kidney disease. Annu Rev Med. 2009;60:321-37. doi: 10.1146/annurev.med.60.101707.125712.
PubMed 18947299Grantham JJ. Clinical practice. Autosomal dominant polycystic kidney disease. N Engl J Med. 2008 Oct 2;359(14):1477-85. doi: 10.1056/NEJMcp0804458. No abstract available.
PubMed 18832246Chang MY, Ong AC. Autosomal dominant polycystic kidney disease: recent advances in pathogenesis and treatment. Nephron Physiol. 2008;108(1):p1-7. doi: 10.1159/000112495. Epub 2007 Dec 13.
PubMed 18075279Neumann J, Ligtenberg G, Klein IH, Blankestijn PJ. Pathogenesis and treatment of hypertension in polycystic kidney disease. Curr Opin Nephrol Hypertens. 2002 Sep;11(5):517-21. doi: 10.1097/00041552-200209000-00007.
PubMed 12187316Chapman AB, Johnson AM, Rainguet S, Hossack K, Gabow P, Schrier RW. Left ventricular hypertrophy in autosomal dominant polycystic kidney disease. J Am Soc Nephrol. 1997 Aug;8(8):1292-7. doi: 10.1681/ASN.V881292.
PubMed 9259356Ecder T, Schrier RW. Hypertension in autosomal-dominant polycystic kidney disease: early occurrence and unique aspects. J Am Soc Nephrol. 2001 Jan;12(1):194-200. doi: 10.1681/ASN.V121194. No abstract available.
PubMed 11134267Chapman AB, Stepniakowski K, Rahbari-Oskoui F. Hypertension in autosomal dominant polycystic kidney disease. Adv Chronic Kidney Dis. 2010 Mar;17(2):153-63. doi: 10.1053/j.ackd.2010.01.001.
PubMed 20219618Cerasola G, Vecchi M, Mule G, Cottone S, Mangano MT, Andronico G, Contorno A, Parrino I, Renda F, Pavone G. Sympathetic activity and blood pressure pattern in autosomal dominant polycystic kidney disease hypertensives. Am J Nephrol. 1998;18(5):391-8. doi: 10.1159/000013382.
PubMed 9730562Klein IHHT, Ligtenberg G, Oey PL, Koomans HA, Blankestijn PJ. Sympathetic activity is increased in polycystic kidney disease and is associated with hypertension. J Am Soc Nephrol. 2001 Nov;12(11):2427-2433. doi: 10.1681/ASN.V12112427.
PubMed 11675419Schrier RW. Hypertension and autosomal dominant polycystic kidney disease. Am J Kidney Dis. 2011 Jun;57(6):811-3. doi: 10.1053/j.ajkd.2011.02.379. No abstract available.
PubMed 21601126Chapman AB, Torres VE, Perrone RD, Steinman TI, Bae KT, Miller JP, Miskulin DC, Rahbari Oskoui F, Masoumi A, Hogan MC, Winklhofer FT, Braun W, Thompson PA, Meyers CM, Kelleher C, Schrier RW. The HALT polycystic kidney disease trials: design and implementation. Clin J Am Soc Nephrol. 2010 Jan;5(1):102-9. doi: 10.2215/CJN.04310709.
PubMed 20089507Torres VE, Chapman AB, Perrone RD, Bae KT, Abebe KZ, Bost JE, Miskulin DC, Steinman TI, Braun WE, Winklhofer FT, Hogan MC, Oskoui FR, Kelleher C, Masoumi A, Glockner J, Halin NJ, Martin DR, Remer E, Patel N, Pedrosa I, Wetzel LH, Thompson PA, Miller JP, Meyers CM, Schrier RW; HALT PKD Study Group. Analysis of baseline parameters in the HALT polycystic kidney disease trials. Kidney Int. 2012 Mar;81(6):577-85. doi: 10.1038/ki.2011.411. Epub 2011 Dec 28.
PubMed 22205355Gattone VH 2nd, Siqueira TM Jr, Powell CR, Trambaugh CM, Lingeman JE, Shalhav AL. Contribution of renal innervation to hypertension in rat autosomal dominant polycystic kidney disease. Exp Biol Med (Maywood). 2008 Aug;233(8):952-7. doi: 10.3181/0802-RM-54. Epub 2008 May 14.
PubMed 18480417Chapuis O, Sockeel P, Pallas G, Pons F, Jancovici R. Thoracoscopic renal denervation for intractable autosomal dominant polycystic kidney disease-related pain. Am J Kidney Dis. 2004 Jan;43(1):161-3. doi: 10.1053/j.ajkd.2003.07.026.
PubMed 14712440
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study Investigating the Effect of Bilateral Renal Artery Sympathetic Denervation by Catheter-based Radiofrequency Ablation on Blood Pressure and Disease Progression in Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT01932450
- Acronym / sponsor ID
- RAFALE / CZKIPLA-ADPKD-001
- Keywords
- hypertension, radiofrequency ablation, autosomal dominant polycystic kidney disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mei changlinUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 30 Aug 2013 (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.
A randomized, open-label single-center study investigates the efficacy and safety of bilateral renal artery sympathetic denervation by catheter-based radiofrequency ablation on blood pressure and disease progression control in autosomal dominant polycystic kidney disease(ADPKD). The total number of study subjects will be 100. All of them have diagnosed with ADPKD and hypertension. Patients will be randomized 1:1 (50 with radiofrequency ablation(RFA), 50 only with drugs). Change in average office-based measurements of systolic blood pressure(SBP), average 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) , incidence of office systolic blood pressure reductions of ≥10, ≥15 and ≥20 mm Hg , office diastolic blood pressure (DBP), number and dosage of blood pressure tablets, total kidney volume (TKV), total cyst volume (TCV), pain related to cystic kidneys and renal function, will be assessed at 12 months of follow-up. The safety variables will be assessed at every visit of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| renal sympathetic denervation | Experimental | Procedure: renal sympathetic denervation, Drug: antihypertensive drugsOne-time standard bilateral renal sympathetic denervation by catheter-based radiofrequency ablation and using antihypertensive drugs which at least include an angiotensin converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB). |
| antihypertensive drugs | Active comparator | Drug: antihypertensive drugsBlood pressure control in ADPKD patients with hypertension only using antihypertensive drugs which at least include an angiotensin converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with ADPKD.
- Having hypertension, defined as systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg, and currently using 2 antihypertensive drugs and receiving a stable antihypertensive treatment regimen without change in dose or medication in the previous 30 days.
- Male and female patients 20 years to 60 years of age.
- Glomerular Filtration Rate (GFR) ≥30 ml/min/1.73 m2, estimated from serum creatinine using the Chronic Kidney Disease Epidemiology collaboration(CKD-EPI) equation.
- Have followed-up kidney and cyst volume at least 6 months in Shanghai Changzheng Hospital.
Key exclusion criteria (16 listed)
- Documented renal vascular disease.
- Congenital absence of a kidney.
- Systemic illness with renal involvement.
- Spot urine albumin-to-creatinine ratio of >0.5 g/g and/or findings suggestive of kidney disease other than ADPKD.
- Exclusions specific to MRI acquisition and measurement: cardiac pacemaker, presence of MRI incompatible metallic clips or other material, excessive body weight, untreatable claustrophobia.
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 |
|---|---|---|
| renal sympathetic denervationAlso: Percutaneous radiofrequency ablation of renal nerves, Transcatheter renal denervation, renal denervation, renal ablationOne-time standard Catheter-based renal sympathetic denervation will be performed in both renal arteries by radiofrequency ablation. | Procedure or surgery | renal sympathetic denervation |
| antihypertensive drugsantihypertensive drugs have been used from baseline in patients, and will be modified by patient's blood pressure. | Drug | antihypertensive drugs, renal sympathetic denervation |
Primary outcome
office-based measurements of systolic blood pressure
Time frame: baseline and 12 months (day 360±14)
Between-group change in average office-based measurements of systolic blood pressure from baseline to 12 months after randomization and One-time standard bilateral renal sympathetic denervation by catheter-based radiofrequency ablation.
16 secondary outcomes
24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM)
Time frame: baseline and 12 months (day 360±14)
Incidence of office systolic blood pressure reduction
Time frame: baseline and 12 months (day 360±14)
office diastolic blood pressure
Time frame: baseline and 12 months (day 360±14)
number and dosage of blood pressure tablets
Time frame: baseline and 12 months (day 360±14)
estimated Glomerular Filtration Rate(eGFR)
Time frame: baseline and 12 months (day 360±14)
albuminuria
Time frame: baseline and 12 months (day 360±14)
total kidney volume (TKV)
Time frame: baseline and 12 months (day 360±14)
pain
Time frame: baseline and 12 months (day 360±14)
procedure-related complications at femoral puncture site
Time frame: up to 1 year (after radiofrequency ablation)
Renal artery lesion
Time frame: up to 1 year (after radiofrequency ablation)
New renal artery stenosis
Time frame: up to 1 year (after radiofrequency ablation)
Embolic events
Time frame: up to 1 year (after radiofrequency ablation)
hypotension
Time frame: up to 1 year (after radiofrequency ablation)
hypertension.
Time frame: up to 1 year (after radiofrequency ablation)
acute kidney injury
Time frame: up to 1 year (after radiofrequency ablation)
total cyst volume (TCV)
Time frame: baseline and 12 months (day 360±14)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Background: PubMed 17434405Torres VE, Harris PC, Pirson Y. Autosomal dominant polycystic kidney disease. Lancet. 2007 Apr 14;369(9569):1287-1301. doi: 10.1016/S0140-6736(07)60601-1.
- Background: PubMed 18947299Harris PC, Torres VE. Polycystic kidney disease. Annu Rev Med. 2009;60:321-37. doi: 10.1146/annurev.med.60.101707.125712.
- Background: PubMed 18832246Grantham JJ. Clinical practice. Autosomal dominant polycystic kidney disease. N Engl J Med. 2008 Oct 2;359(14):1477-85. doi: 10.1056/NEJMcp0804458. No abstract available.
- Background: PubMed 18075279Chang MY, Ong AC. Autosomal dominant polycystic kidney disease: recent advances in pathogenesis and treatment. Nephron Physiol. 2008;108(1):p1-7. doi: 10.1159/000112495. Epub 2007 Dec 13.
- Background: PubMed 12187316Neumann J, Ligtenberg G, Klein IH, Blankestijn PJ. Pathogenesis and treatment of hypertension in polycystic kidney disease. Curr Opin Nephrol Hypertens. 2002 Sep;11(5):517-21. doi: 10.1097/00041552-200209000-00007.
- Background: PubMed 9259356Chapman AB, Johnson AM, Rainguet S, Hossack K, Gabow P, Schrier RW. Left ventricular hypertrophy in autosomal dominant polycystic kidney disease. J Am Soc Nephrol. 1997 Aug;8(8):1292-7. doi: 10.1681/ASN.V881292.
- Background: PubMed 11134267Ecder T, Schrier RW. Hypertension in autosomal-dominant polycystic kidney disease: early occurrence and unique aspects. J Am Soc Nephrol. 2001 Jan;12(1):194-200. doi: 10.1681/ASN.V121194. No abstract available.
- Background: PubMed 20219618Chapman AB, Stepniakowski K, Rahbari-Oskoui F. Hypertension in autosomal dominant polycystic kidney disease. Adv Chronic Kidney Dis. 2010 Mar;17(2):153-63. doi: 10.1053/j.ackd.2010.01.001.
- Background: PubMed 9730562Cerasola G, Vecchi M, Mule G, Cottone S, Mangano MT, Andronico G, Contorno A, Parrino I, Renda F, Pavone G. Sympathetic activity and blood pressure pattern in autosomal dominant polycystic kidney disease hypertensives. Am J Nephrol. 1998;18(5):391-8. doi: 10.1159/000013382.
- Background: PubMed 11675419Klein IHHT, Ligtenberg G, Oey PL, Koomans HA, Blankestijn PJ. Sympathetic activity is increased in polycystic kidney disease and is associated with hypertension. J Am Soc Nephrol. 2001 Nov;12(11):2427-2433. doi: 10.1681/ASN.V12112427.
- Background: PubMed 21601126Schrier RW. Hypertension and autosomal dominant polycystic kidney disease. Am J Kidney Dis. 2011 Jun;57(6):811-3. doi: 10.1053/j.ajkd.2011.02.379. No abstract available.
- Background: PubMed 20089507Chapman AB, Torres VE, Perrone RD, Steinman TI, Bae KT, Miller JP, Miskulin DC, Rahbari Oskoui F, Masoumi A, Hogan MC, Winklhofer FT, Braun W, Thompson PA, Meyers CM, Kelleher C, Schrier RW. The HALT polycystic kidney disease trials: design and implementation. Clin J Am Soc Nephrol. 2010 Jan;5(1):102-9. doi: 10.2215/CJN.04310709.
Related trials for Autosomal Dominant Polycystic Kidney Disease
RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Active, not recruitingObservational study
Role of ROS and cAMP-PKA Biomarkers in ADPKD
Autosomal Dominant Polycystic Kidney Disease
Not yet recruitingPhase 1
A Study to Investigate the Pharmacokinetics of JMKX003142 in Healthy Participants and Participants With Hepatic Impairment
ADPKD (Autosomal Dominant Polycystic Kidney Disease), Renal Edema
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
Changlin Mei, MD principal investigator
Nephrology Department of Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing renal sympathetic denervation and antihypertensive drugs in people with Autosomal Dominant Polycystic Kidney Disease and Hypertension, run by Mei changlin at 1 site in China.
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 16 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: status not confirmed, as of the sponsor's last update on 25 Sep 2014. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Changlin Mei, MD (+86 21 81885391, chlmei1954@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
office-based measurements of systolic blood pressure (time frame: baseline and 12 months (day 360±14)). 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 NCT01932450, which also lists 39 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 25 Sep 2014.