HALT Progression of Polycystic Kidney Disease (HALT PKD) Study A
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ClinicalTrials.gov Identifier: NCT00283686 |
Recruitment Status
:
Completed
First Posted
: January 30, 2006
Results First Posted
: February 27, 2015
Last Update Posted
: March 19, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Kidney, Polycystic | Drug: Lisinopril Drug: Telmisartan Drug: Placebo Other: Standard Blood Pressure Control Other: Low Blood Pressure Control | Phase 3 |
* Specific Aims of Study A
To study the efficacy of angiotensin-converting-enzyme inhibitor (ACE-I) and angiotensin-receptor blockade (ARB) combination therapy as compared to ACE-I monotherapy and usual vs. low blood pressure targets on the percent change in kidney volume in participants with preserved renal function (GFR >60 mL/min/1.73m2)and high-normal blood pressure or hypertension (>130/80 mm Hg).
* Hypotheses to be tested in Study A
In ADPKD individuals with hypertension or high-normal blood pressure and relatively preserved renal function (GFR >60 mL/min/1.73 m2), multi-level blockade of the RAAS using ACE-I/ARB combination therapy will delay progression of cystic disease as compared to ACE-I monotherapy, and a low blood pressure goal will delay progression as compared with standard control.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 558 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Polycystic Kidney Disease-Treatment Network |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Study A, Arm 1
Lisinopril + Telmisartan (ACE-I + ARB) and standard blood pressure control of 120-130/70-80 mm Hg
|
Drug: Lisinopril
Lisinopril titrated to 5mg, 10mg, 20mg, 40mg
Other Names:
Drug: Telmisartan
Telmisartan/Placebo titrated to 40mg and 80mg, as tolerated by participants
Other Name: ARB
Other: Standard Blood Pressure Control
Achieve standard blood pressure control of 120-130/70-80 mm Hg using step dosing specified in protocol of lisinopril, study drug, hydrochlorothiazide, metoprolol, or non-dihydropyridine and dihydropyridine calcium channel blockers (diltiazem), clonidine, minoxidil, hydralazine at the discretion of the investigator
Other Name: blood pressure control
|
Active Comparator: Study A, Arm 2
Lisinopril + Telmisartan (ACE-I + ARB) and low blood pressure control of 95-110/60-75 mm Hg
|
Drug: Lisinopril
Lisinopril titrated to 5mg, 10mg, 20mg, 40mg
Other Names:
Drug: Telmisartan
Telmisartan/Placebo titrated to 40mg and 80mg, as tolerated by participants
Other Name: ARB
Other: Low Blood Pressure Control
Achieve low blood pressure control of 95-110/60-75 mm Hg using step dosing specified in protocol of lisinopril, study drug, hydrochlorothiazide, metoprolol, or non-dihydropyridine and dihydropyridine calcium channel blockers (diltiazem), clonidine, minoxidil, hydralazine at the discretion of the investigator
Other Name: blood pressure control
|
Placebo Comparator: Study A, Arm 3
Lisinopril + Placebo (ACE-I + Placebo) and standard blood pressure control of 120-130/70-80 mm Hg
|
Drug: Lisinopril
Lisinopril titrated to 5mg, 10mg, 20mg, 40mg
Other Names:
Drug: Placebo
Telmisartan/Placebo titrated to 40mg and 80mg, as tolerated by participants
Other: Standard Blood Pressure Control
Achieve standard blood pressure control of 120-130/70-80 mm Hg using step dosing specified in protocol of lisinopril, study drug, hydrochlorothiazide, metoprolol, or non-dihydropyridine and dihydropyridine calcium channel blockers (diltiazem), clonidine, minoxidil, hydralazine at the discretion of the investigator
Other Name: blood pressure control
|
Placebo Comparator: Study A, Arm 4
Lisinopril + Placebo (ACE-I + Placebo) and low blood pressure control of 95-110/60-75 mm Hg
|
Drug: Lisinopril
Lisinopril titrated to 5mg, 10mg, 20mg, 40mg
Other Names:
Drug: Placebo
Telmisartan/Placebo titrated to 40mg and 80mg, as tolerated by participants
Other: Low Blood Pressure Control
Achieve low blood pressure control of 95-110/60-75 mm Hg using step dosing specified in protocol of lisinopril, study drug, hydrochlorothiazide, metoprolol, or non-dihydropyridine and dihydropyridine calcium channel blockers (diltiazem), clonidine, minoxidil, hydralazine at the discretion of the investigator
Other Name: blood pressure control
|
- Study A: Percent Annual Change in Total Kidney Volume [ Time Frame: Baseline and 2-, 4- and 5-year follow-up ]Annual percentage change in total kidney volume as assessed by abdominal magnetic resonance imaging (MRI) at baseline, 2 years, 4 years, and 5 years follow-up.
- Kidney Function (eGFR) [ Time Frame: Up to 96 months (6 month assessments) ]The estimated GFR was calculated by means of the Chronic Kidney Disease Epidemiology Collaboration equation with the use of central serum creatinine measurements.
- Albuminuria [ Time Frame: Up to 96 months (assessed annually) ]Urine albumin excretion, centrally processed from 24 hour urine collection
- Aldosterone [ Time Frame: Up to 96 months (assessed annually) ]Urinary aldosterone excretion, centrally processed, 24 hour urine collection
- Left Ventricular Mass Index [ Time Frame: 0, 24 months, 48 months, 60 months ]Left ventricular mass index (g/m^2) measured by MRI, centrally reviewed and measured
- Renal Blood Flow [ Time Frame: 0, 24 months, 48 months, 60 months ]renal blood flow (mL/min/1.73 m^2) from MRI, centrally reviewed and measured. This outcome was more difficult to measure resulting in more missing data than other MRI outcomes such as total kidney volume (TKV) and left ventricular mass index (LVMI).
- All-Cause Hospitalizations [ Time Frame: Up to 96 months ]
- Quality of Life Physical Component Summary [ Time Frame: baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually) ]Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome)
- Quality of Life Mental Component Summary [ Time Frame: baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually) ]Short Form-36 Quality of LIfe Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome)

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Ages Eligible for Study: | 15 Years to 64 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of ADPKD.
- Age 15-49 (Study A); Age 18-64 (Study B).
- GFR >60 mL/min/1.73 m2 (Study A); GFR 25-60 mL/min/1.73 m2 (Study B).
- BP ≥130/80 or receiving treatment for hypertension.
- Informed Consent.
Exclusion Criteria:
- Pregnant/intention to become pregnant in 4-6 yrs.
- Documented renal vascular disease.
- Spot urine albumin-to-creatinine ratio of >0.5 (Study A) or ≥1.0 (Study B) and/or findings suggestive of kidney disease other than ADPKD.
- Diabetes requiring insulin or oral hypoglycemic agents / fasting serum glucose of >126 mg/dl / random non-fasting glucose of >200 mg/dl.
- Serum potassium >5.5 milliequivalent per liter (mEq/L) for participants currently on ACE-I or ARB; >5.0 mEq/L for participants not currently on ACE-I or ARB.
- History of angioneurotic edema or other absolute contraindication for ACE-I or ARB. Intolerable cough associated with ACE-I is defined as a cough developing within six months of initiation of ACE-I in the absence of other causes and resolving upon discontinuation of the ACE-I.
- Indication (other than hypertension) for β-blocker or calcium channel blocker therapy (e.g. angina, past myocardial infarction, arrhythmia), unless approved by the site principal investigator. (PI may choose to accept an individual who is on only a small dose of one of these agents and would otherwise be eligible.)
- Systemic illness necessitating nonsteroidal antiinflammatory drugs (NSAIDs), immunosuppressant or immunomodulatory medications.
- Systemic illness with renal involvement.
- Hospitalized for acute illness in past 2 months.
- Life expectancy <2 years.
- History of non-compliance.
- Unclipped cerebral aneurysm >7mm diameter.
- Creatine supplements within 3 months of screening visit.
- Congenital absence of a kidney (also total nephrectomy for Study B).
- Known allergy to sorbitol or sodium polystyrene sulfonate.
- Exclusions specific to magnetic resonance imaging (Study A).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283686
United States, Colorado | |
University of Colorado Health Sciences Center | |
Denver (Aurora), Colorado, United States, 800045 | |
United States, Georgia | |
Emory University School of Medicine | |
Atlanta, Georgia, United States, 30322 | |
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 | |
United States, Massachusetts | |
Tufts University-New England Medical Center | |
Boston, Massachusetts, United States, 02111 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 |
Study Chair: | Robert Schrier, M.D. | University of Colorado, Denver | |
Principal Investigator: | Arlene Chapman, M.D. | Emory University | |
Principal Investigator: | Ronald Perrone, M.D. | Tufts University-New England Medical Center | |
Principal Investigator: | Vicente Torres, M.D. | Mayo Clinic | |
Study Director: | Marva Moxey-Mims, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |
Principal Investigator: | Charity G Moore, MS,PhD | University of Pittsburgh |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Charity G Moore, PhD, Professor of Medicine, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00283686 History of Changes |
Other Study ID Numbers: |
DK62401-PKD-TN (IND) |
First Posted: | January 30, 2006 Key Record Dates |
Results First Posted: | February 27, 2015 |
Last Update Posted: | March 19, 2015 |
Last Verified: | March 2015 |
Keywords provided by Charity G Moore, PhD, University of Pittsburgh:
pkd polycystic kidney disease polycystic kidney disease adpkd halt |
blood pressure bp hypertension renal renin-angiotensin-aldosterone-system RAAS |
Additional relevant MeSH terms:
Kidney Diseases Polycystic Kidney Diseases Urologic Diseases Kidney Diseases, Cystic Abnormalities, Multiple Congenital Abnormalities Genetic Diseases, Inborn Telmisartan Hydrochlorothiazide Lisinopril Calcium Channel Blockers Antihypertensive Agents Diuretics |
Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Cardiotonic Agents Protective Agents |