Resistant Hypertension in Kidney Transplant PatientsPhase 4NCT02030314
The Management of Resistant Hypertension in Kidney Transplant Patients Using Chlorthalidone
A Phase 4 study testing Chlorthalidone in people with Resistant Hypertension in Kidney Transplant Patients, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Chlorthalidone might offer an effective, safe and inexpensive anti-hypertensive treatment for kidney transplant patients who have resistant hypertension on multi-drug therapy. We will collect initial data on the safety and efficacy of Chlorthalidone in the treatment of patients with resistant hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resistant Hypertension in Kidney Transplant Patients
- What is being tested?
- Chlorthalidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 12 Apr 2017
- Phase
- Phase 4
- 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
- Agree to participate in study
- Patients after kidney transplantation> 6 months post-transplant.
- Age>18 years
- Home or office Systolic Blood pressure >140 confirmed with daytime 24-h ABPM of average systolic blood pressure >140.
- Tacrolimus/Cyclosporine therapy with therapeutic trough level based upon historical values
- Stable renal function for at least 3 months before enrollment.
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- Historical Baseline estimated Glomerular Filtration Rate >30mL/min
- No more than trace edema on physical examination at time of initial assessment.
- Receiving optimal doses of ≥ 3 anti-hypertensive medications including furosemide at ≤80mg/d.9.
- 8-10 in morning sitting Plasma aldosterone Concentration < 15ng/dL and Plasma Renin Activity <0.6ng/mL/h
Who cannot join
- Serum sodium<135meq/L based upon historical values
- Serum potassium<3.5meq/L based upon historical values
- Poorly controlled diabetes mellitus with HbA1c>9% based upon historical values
- Already on thiazide
- Arm circumference >42cm
- Clinically significant hepatic dysfunction based upon medical history or historical values
Show all 10Show fewer
- Two (2) Unsuccessful baseline ABPMs
- Poor adherence in run-in period as suggested by an unsuccessful 24-h urine collection.
- DBP≥110 or SBP≥200
- Allergy to Chlorthalidone
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealtlh University
Richmond, Virginia, 23298
About this study
Chlorthalidone might offer an effective, safe and inexpensive anti-hypertensive treatment for kidney transplant patients who have resistant hypertension on multi-drug therapy. We will collect initial data on the safety and efficacy of Chlorthalidone in the treatment of patients with resistant hypertension.
To Examine the efficacy of chlorthalidone as an anti-hypertensive agent in the treatment of resistant hypertension among stable kidney transplant recipients
Read the detailed description
The study involves transplant recipients presenting to the transplant Clinic Gateway 7th floor with resistant hypertension. The initial contact will take place in the transplant clinic study consist of approximately eight out patient visits over a 8 week period: Screening, and follow-up visits will be conducted at the Clinical Research Services (CRS) Unit. The Baseline (Week 1), Visit 1 Enrollment (Week 1) Day 1 and 2, Visit 2, (Week 3) Day 1 and 2, and Visit 3 End of Study, (Week 7) Day 1 and 2. Additional visits maybe required to accommodate adverse reactions. The study will require approximately four (4) time points where blood pressure, pulse and weight is obtained, safety blood collections approximately 2-3 tablespoons drawn by venipuncture and 24 hour urine collection periods. Home blood pressure readings will be required at two (2) time points during the study. The subject will be required to stop taking current medications for seven weeks, take study medication for 6 weeks and report adverse reactions and concomitant medications at each visit.
During the Enrollment visit, the subject will be identified, informed consent obtained, demographic characteristics, past medical history, co-morbid illnesses, current medications, and home and office blood pressures will be recorded to assess for eligibility criteria. This data will be collected prospectively by the investigators.
Initial clinical assessment at the time of the patient's screening visit will be performed at the outpatient testing center in the transplant clinic. A three day window will be allowed for all visits. The following measurements will occur at this visit: Biometric measurements: vitals ( blood pressure and pulse) body weight, EKG, Arm circumference, confirmation of hypertension by 24-h ABPM , urine studies: 24 hour urine collection and evaluation, safety, 8-10AM sitting upright Plasma Aldosterone/Renin Ratio, clinical safety laboratory test: bone morphogenetic protein, Mg/phosphorus level, Parathyroid hormone, vitamin D level and HbA1c, review and document concomitant medications, including current furosemide prescription. Subjects who meet the inclusion criteria and none of the exclusion criteria will start Baseline (Week 1) Measurements.
At Baseline (Week 1) the current furosemide prescription will be documented and discontinued. This will begin the washout period. The washout period will continue for one week. At the end of the washout period the subject will be instructions to return to the CRS unit for Visit 1 Enrollment measurements.
Visit 1 Enrollment Measurements Week 1, Day 1, include the following measurements: Biometric measurements: Body Weight, confirmation of hypertension by 24-h ABPM Urine studies: start 24 hour Urine collection, safety laboratory evaluations: bone morphogenetic protein , document concomitant medications, and adverse reactions. Visit 1 Enrollment Measurements Week 1 Day 2 the subject will return the 24-hour urine collection and the 24 hour ABPM will be removed. The study medication chlorthalidone will be started. The subject will take study medication for 3 weeks before returning for the next study visit: Visit 2 (Week 3) Day 1 . A three day window will be allowed.
At Visit 2 (Week 3) Day 1 and 2. Biometric measurements: Body Weight and home B/P recordings, start 24 hour Urine collection. Review pill count for compliance, concomitant medications and adverse reactions will be obtained. Day 2: the subject will return the 24-hour urine collection. Review study removal criteria After taking the study medication for three weeks, the subject will return to the CRS unit for Visit 3 End of Study, (Week 7) Day 1 and 2 Visit 3 End of Study, (Week 7) Day 1 and 2. On day 1, Biometric measurements: Body Weight, start 24-h ABPM , Urine studies: start 24 hour Urine collection, safety laboratory evaluations: 8-10AM sitting upright Plasma Aldosterone/Renin Ratio, collect safety labs: bone morphogenetic protein, Mg/phosphorus level, parathyroid hormone, vitamin D level and HbA1c, document pill count, concomitant medications, home blood pressure readings and adverse Reactions. Day 2: the subject will return the 24-hour urine collection and the 24 hour ABPM will be removed If blood pressure is adequately controlled on study medication subject may continue study medication. If blood pressure not adequately controlled on study medication the subject may return to pre-study medication or a medication prescribed by physician.
- Being tested
- Chlorthalidone
- Keywords
- Chlorthalidone, Resistant Hypertension, Kidney Transplant Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorthalidoneDrug
Also called Thalitone
treatment of resistant hypertension in kidney transplant patients
| Study group | Role | What they receive |
|---|---|---|
| chlorthalidone, resistant high blood pressure | Experimental | if Furosemide dose is 40 mg per day, start Chlorthalidone 12.5 mg per day if Furosemide dose is 80 mg per day, start Chlorthalidone 25 mg per day Receives: Drug: Chlorthalidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from mean baseline systolic blood pressure (by ABPM) between week 0, 1 and 7, ANOVA ABPM at baseline, week 1 and end of the study, Least-squares mean and standard error of the mean for changes in blood pressure measures,
To examine the efficacy of Chlorthalidone as an antihypertensive agent in the treatment of resistant hypertension among stable kidney transplant recipients
Measured: Week 1, week 3, and end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startJul 2013
- Primary completion12 Apr 2017
- Study completion12 Apr 2017
Why it stopped: The patient population changed. Unable to find patients that meet study criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resistant Hypertension in Kidney Transplant PatientsStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaurav Gupta, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030314
- Sponsor's protocol ID
- HM20002960
- Status last verified
- Jun 2017
- First submitted
- 19 Dec 2013
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.
PubMed 39082471
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management of Resistant Hypertension in Kidney Transplant Patients Using Chlorthalidone
- ClinicalTrials.gov ID
- NCT02030314
- Acronym / sponsor ID
- HM20002960
- Keywords
- Chlorthalidone, Resistant Hypertension, Kidney Transplant Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The patient population changed. Unable to find patients that meet study criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- 12 Apr 2017 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 8 Jan 2014 (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.
Chlorthalidone might offer an effective, safe and inexpensive anti-hypertensive treatment for kidney transplant patients who have resistant hypertension on multi-drug therapy. We will collect initial data on the safety and efficacy of Chlorthalidone in the treatment of patients with resistant hypertension.
To Examine the efficacy of chlorthalidone as an anti-hypertensive agent in the treatment of resistant hypertension among stable kidney transplant recipients
Detailed description
The study involves transplant recipients presenting to the transplant Clinic Gateway 7th floor with resistant hypertension. The initial contact will take place in the transplant clinic study consist of approximately eight out patient visits over a 8 week period: Screening, and follow-up visits will be conducted at the Clinical Research Services (CRS) Unit. The Baseline (Week 1), Visit 1 Enrollment (Week 1) Day 1 and 2, Visit 2, (Week 3) Day 1 and 2, and Visit 3 End of Study, (Week 7) Day 1 and 2. Additional visits maybe required to accommodate adverse reactions. The study will require approximately four (4) time points where blood pressure, pulse and weight is obtained, safety blood collections approximately 2-3 tablespoons drawn by venipuncture and 24 hour urine collection periods. Home blood pressure readings will be required at two (2) time points during the study. The subject will be required to stop taking current medications for seven weeks, take study medication for 6 weeks and report adverse reactions and concomitant medications at each visit.
During the Enrollment visit, the subject will be identified, informed consent obtained, demographic characteristics, past medical history, co-morbid illnesses, current medications, and home and office blood pressures will be recorded to assess for eligibility criteria. This data will be collected prospectively by the investigators.
Initial clinical assessment at the time of the patient's screening visit will be performed at the outpatient testing center in the transplant clinic. A three day window will be allowed for all visits. The following measurements will occur at this visit: Biometric measurements: vitals ( blood pressure and pulse) body weight, EKG, Arm circumference, confirmation of hypertension by 24-h ABPM , urine studies: 24 hour urine collection and evaluation, safety, 8-10AM sitting upright Plasma Aldosterone/Renin Ratio, clinical safety laboratory test: bone morphogenetic protein, Mg/phosphorus level, Parathyroid hormone, vitamin D level and HbA1c, review and document concomitant medications, including current furosemide prescription. Subjects who meet the inclusion criteria and none of the exclusion criteria will start Baseline (Week 1) Measurements.
At Baseline (Week 1) the current furosemide prescription will be documented and discontinued. This will begin the washout period. The washout period will continue for one week. At the end of the washout period the subject will be instructions to return to the CRS unit for Visit 1 Enrollment measurements.
Visit 1 Enrollment Measurements Week 1, Day 1, include the following measurements: Biometric measurements: Body Weight, confirmation of hypertension by 24-h ABPM Urine studies: start 24 hour Urine collection, safety laboratory evaluations: bone morphogenetic protein , document concomitant medications, and adverse reactions. Visit 1 Enrollment Measurements Week 1 Day 2 the subject will return the 24-hour urine collection and the 24 hour ABPM will be removed. The study medication chlorthalidone will be started. The subject will take study medication for 3 weeks before returning for the next study visit: Visit 2 (Week 3) Day 1 . A three day window will be allowed.
At Visit 2 (Week 3) Day 1 and 2. Biometric measurements: Body Weight and home B/P recordings, start 24 hour Urine collection. Review pill count for compliance, concomitant medications and adverse reactions will be obtained. Day 2: the subject will return the 24-hour urine collection. Review study removal criteria After taking the study medication for three weeks, the subject will return to the CRS unit for Visit 3 End of Study, (Week 7) Day 1 and 2 Visit 3 End of Study, (Week 7) Day 1 and 2. On day 1, Biometric measurements: Body Weight, start 24-h ABPM , Urine studies: start 24 hour Urine collection, safety laboratory evaluations: 8-10AM sitting upright Plasma Aldosterone/Renin Ratio, collect safety labs: bone morphogenetic protein, Mg/phosphorus level, parathyroid hormone, vitamin D level and HbA1c, document pill count, concomitant medications, home blood pressure readings and adverse Reactions. Day 2: the subject will return the 24-hour urine collection and the 24 hour ABPM will be removed If blood pressure is adequately controlled on study medication subject may continue study medication. If blood pressure not adequately controlled on study medication the subject may return to pre-study medication or a medication prescribed by physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chlorthalidone, resistant high blood pressure | Experimental | Drug: Chlorthalidoneif Furosemide dose is 40 mg per day, start Chlorthalidone 12.5 mg per day if Furosemide dose is 80 mg per day, start Chlorthalidone 25 mg per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Agree to participate in study
- Patients after kidney transplantation> 6 months post-transplant.
- Age>18 years
- Home or office Systolic Blood pressure >140 confirmed with daytime 24-h ABPM of average systolic blood pressure >140.
- Tacrolimus/Cyclosporine therapy with therapeutic trough level based upon historical values
Key exclusion criteria (10 listed)
- Serum sodium<135meq/L based upon historical values
- Serum potassium<3.5meq/L based upon historical values
- Poorly controlled diabetes mellitus with HbA1c>9% based upon historical values
- Already on thiazide
- Arm circumference >42cm
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 |
|---|---|---|
| ChlorthalidoneAlso: Thalitonetreatment of resistant hypertension in kidney transplant patients | Drug | chlorthalidone, resistant high blood pressure |
Primary outcome
Change from mean baseline systolic blood pressure (by ABPM) between week 0, 1 and 7, ANOVA ABPM at baseline, week 1 and end of the study, Least-squares mean and standard error of the mean for changes in blood pressure measures,
Time frame: Week 1, week 3, and end of study
To examine the efficacy of Chlorthalidone as an antihypertensive agent in the treatment of resistant hypertension among stable kidney transplant recipients
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Derived from this study: PubMed 39082471Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.
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.
Gaurav Gupta, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorthalidone in people with Resistant Hypertension in Kidney Transplant Patients, run by Virginia Commonwealth University 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 10 inclusion and 10 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: withdrawn, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 from mean baseline systolic blood pressure (by ABPM) between week 0, 1 and 7, ANOVA ABPM at baseline, week 1 and end of the study, Least-squares mean and standard error of the mean for changes in blood pressure measures, (time frame: Week 1, week 3, and end of study). 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 NCT02030314, which also lists 1 linked publication.
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 15 Jun 2017.