IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
HALT Progression of Polycystic Kidney Disease (HALT PKD) Study B (HALT-PKD)
This study has been completed.
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators:
Boehringer Ingelheim
Merck Sharp & Dohme Corp.
Polycystic Kidney Disease Foundation
Information provided by (Responsible Party):
Charity G Moore, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01885559
First received: June 17, 2013
Last updated: February 25, 2015
Last verified: February 2015
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR >60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years.
Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.
| Condition | Intervention | Phase |
|---|---|---|
| Kidney, Polycystic | Drug: Lisinopril Drug: Telmisartan Drug: Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Polycystic Kidney Disease-Treatment Network |
Resource links provided by NLM:
Genetics Home Reference related topics:
polycystic kidney disease
MedlinePlus related topics:
Kidney Diseases
U.S. FDA Resources
Further study details as provided by Charity G Moore, PhD, University of Pittsburgh:
Primary Outcome Measures:
- Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death. [ Time Frame: Patients followed for 5-8 years with average of 6.5 years follow up ]
Secondary Outcome Measures:
- Albuminuria [ Time Frame: up to 8 years (annually assessed) ]Annual percent change in 24 hour urine albumin, centrally processed. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope of the model). The measure presented is the average annual percent change across the 8 years.
- Aldosterone [ Time Frame: up at 8 years (annually assessed) ]Annual percent change in urinary aldosterone, centrally processed measure. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual percent change across the 8 years.
- Hospitalizations [ Time Frame: up to 8 years ]Hospitalization for any cause
- Cardiovascular Hospitalizations [ Time Frame: up to 8 years ]Cause-specific hospitalizations (cardiovascular)
- Quality of Life Physical Component Summary [ Time Frame: up to 8 years (annually assessed) ]Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years.
- Quality of Life Mental Component Summary [ Time Frame: up to 8 years (annually assessed) ]Short Form-36 Quality of Life Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years.
- Pain [ Time Frame: 48 months ]Kidney pain (back or flank pain) experienced in since last visit
| Enrollment: | 486 |
| Study Start Date: | January 2006 |
| Study Completion Date: | June 2014 |
| Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: ACE-I + placebo
Monotherapy of lisinopril and placebo. Standard blood pressure control of 110-130/80 mm Hg
|
Drug: Lisinopril
Lisinopril titrated to 5mg, 10mg, 20mg, 40mg as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
Other Names:
Drug: Placebo
Placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
Other Name: Control
|
|
Active Comparator: ACE-I + ARB
Dual therapy of lisinopril and telmisartan treatments. Standard blood pressure control of 110-130/80 mm Hg.
|
Drug: Lisinopril
Lisinopril titrated to 5mg, 10mg, 20mg, 40mg as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
Other Names:
Drug: Telmisartan
Telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
Other Name: ARB
|
Detailed Description:
* Specific Aim of Study B
To study the effects of ACE-I/ARB combination therapy as compared to ACE-I monotherapy in the setting of standard blood pressure control (110-130/80 mm Hg) on the time to a 50% reduction of baseline estimated Glomerular Filtration Rate (eGFR), end-state renal disease (ESRD) or death, in hypertensive individuals with moderate renal insufficiency (GFR 25-60 mL/min/1.73m2).
* Hypothesis to be tested in Study B
In hypertensive ADPKD individuals with moderate renal insufficiency (GFR 25-60 mL/min/1.73 m2), intensive blockade of the RAAS using combination ACE-I/ARB therapy will slow the decline in kidney function over ACE-I monotherapy, independent of standard blood pressure control (110-130/80 mm Hg).
Eligibility| Ages Eligible for Study: | 15 Years to 64 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 (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 (MR) imaging (Study A).
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01885559
Please refer to this study by its ClinicalTrials.gov identifier: NCT01885559
Locations
| 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 | |
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Boehringer Ingelheim
Merck Sharp & Dohme Corp.
Polycystic Kidney Disease Foundation
Investigators
| 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, PhD | University of Pittsburgh |
More Information
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: | NCT01885559 History of Changes |
| Obsolete Identifiers: | NCT00067977 |
| Other Study ID Numbers: |
DK62401-PKD-TN (IND) |
| Study First Received: | June 17, 2013 |
| Results First Received: | February 2, 2015 |
| Last Updated: | February 25, 2015 |
Keywords provided by Charity G Moore, PhD, University of Pittsburgh:
|
polycystic kidney disease polycystic kidney disease adpkd halt pkd |
blood pressure bp hypertension renal renin-angiotensin-aldosterone-system RAAS |
Additional relevant MeSH terms:
|
Kidney Diseases Polycystic Kidney Diseases Urologic Diseases Kidney Diseases, Cystic Telmisartan Lisinopril Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers |
Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Cardiotonic Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 19, 2017