Hypertensive NephrosclerosisPhase 3AASKNCT04364139

African American Study of Kidney Disease and Hypertension

A Phase 3 study testing MAP goal less than or equal to 92 mm Hg, MAP goal 102-107 mm Hg and Ramipril in people with Hypertensive Nephrosclerosis and Chronic Renal Insufficiency, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hypertensive Nephrosclerosis, Chronic Renal Insufficiency
What is being tested?: MAP goal less than or equal to 92 mm Hg, MAP goal 102-107 mm Hg and Ramipril
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,094 participants
Where: No sites listed yet
Study dates: 1 Feb 1995to 30 Jun 2007
Phase: Phase 3
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

African-American men and women (including black individuals born in the Caribbean, Africa, Canada, etc.) age 18 to 70 years. Each center will attempt to include equal numbers of men and women, at least 1:3 of each.
Hypertension is defined as a sitting diastolic BP of 95 mmHg or more. The average of the last two of three consecutive readings on a random zero sphygmomanometer machine at any visit is the level used. Hypertensive participants on anti-hypertensive therapy at Baseline need only one qualifying clinic visit. Those not currently on medications at Baseline must qualify on each of two consecutive clinic visits.
Reduced renal function, defined as a prerandomization (G1 visit) 125I-iothalamate GFR between 20 to 65 ml/min 1.73 per m^2.
Willingness and ability to cooperate with the protocol.

Who cannot join

History of malignant or accelerated hypertension within 6 mo prior to study entry; previous chronic peritoneal or hemodialysis or renal transplantation.
Known secondary causes of hypertension.
Any known history of diabetes mellitus type I and II, or fasting (8-12 h) glucose >140 mg/dl on two occasions, or glucose >200 mg/dl on one occasion prior to randomization.
A ratio of urinary protein (mg/dl) to creatinine (mg/dl) exceeding 2.5 in a 24-h urine sample collected shortly before the initial GFR visit. (This ratio is used as an estimate of > 2.5 g/d proteinuria without needing to factor for validity of the collection.)
Clinical or renal biopsy evidence of any renal disease other than hypertensive nephrosclerosis. Persons with arteriographically documented renal arterial atherosclerotic disease less than 50% stenosis of the renal artery should be considered eligible for study participation if the principal investigator at the center feels the disease is not clinically significant.
History of drug abuse in the past 2 yr, including narcotics, cocaine, or alcohol (>21 drinks/wk).

Show all 21Show fewer

Serious systemic disease that might influence survival or the course of renal disease. (Chronic oral steroid therapy is an exclusion, but steroid-containing nasal sprays are not. In active sarcoidosis is not an exclusion.)
Clinical evidence of lead intoxication.
Arm circumference >52 cm, which precludes measuring blood pressure with the "thigh" blood pressure cuff. Arm length such that if the cuff that is appropriate for the arm circumference extends into the antecubital space so that the cuff would interfere with placement of the stethoscope over the brachial artery for blood pressure measurement.
Clinical evidence of congestive heart failure, current or within the preceding 6 mn. Ejection fraction below 35% measured by any method. Heart block greater than first degree or any other arrhythmia that would contraindicate the use of any of the randomized drugs.
Reactive airway disease, current or in the preceding 6 mo requiring prescribed treatment for more than 2 wk.
Impairment or difficulty in voiding, precluding adequate urine collections.
Intake of nonsteroidal anti-inflammatory agents (NSAIDs) more than 15 d/mo, excluding aspirin. Inability to discontinue NSAIDs or aspirin for 5 d prior to GFR measurement.
History of severe adverse reaction to any of the randomized drugs required for use in the protocol or contraindication of their use.
Pregnancy or likelihood of becoming pregnant during the study period; lactation.
Serum potassium level >5.5 mEq/L at the study visit 2 (SV2) and confirmed at G1 for those not on ACE inhibitors during baseline, or serum potassium level >5.9 mEq/L at the SV2 and confirmed at G1 for those on ACE inhibitors during baseline.
Leukopenia <2,500/mm3 at SV2 and confirmed at the end of baseline.
Medically indicated need for any of the randomized drugs for any other reason (including angina pectoris, migraine, arrhythmia).
Allergy to iodine.
Suspicion that the participant will not be able to adhere to medications or comply with the protocol visit schedule.
Participation in another intervention study.

About this study

Read the detailed description

The AASK is a multicenter, randomized, controlled clinical trial using a 2 × 3 factorial design to evaluate the effects of level of blood pressure control and type of anti-hypertensive medication on progression of chronic renal disease among African American men and women with chronic renal insufficiency caused by hypertension (hypertensive nephrosclerosis). Two levels of blood pressure control were defined in terms of mean arterial pressure (MAP = 2/3 diastolic blood pressure + 1/3 systolic blood pressure). A usual goal is defined as an MAP of 102 to 107 mm Hg, and a low goal is defined as an MAP of 92 mm Hg or less. The three antihypertensive drug regimens contained either a calcium channel blocker (amlodipine), β-blocker (metoprolol; Toprol XL), or angiotensin-converting enzyme inhibitor (ramipril) as initial therapy. Progression of renal disease was measured as the rate of decline in glomerular filtration rate (GFR).

Conditions: Hypertensive Nephrosclerosis, Chronic Renal Insufficiency
Being tested: MAP goal less than or equal to 92 mm Hg, MAP goal 102-107 mm Hg, Ramipril, Amlodipine, Metoprolol
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MAP goal less than or equal to 92 mm HgOther
Lower Blood Pressure Goal (mean arterial pressure (MAP) less than or equal to 92 mm Hg) which corresponds to a BP of approximately 115/80 mmHg
MAP goal 102-107 mm HgOther
Usual Blood Pressure Goal (mean arterial pressure (MAP) 102-107 mm Hg) which corresponds to a BP of approximately 135/85 to 140/90 mmHg
RamiprilDrug
Also called ACEI
An angiotensin-converting enzyme inhibitor, (ACEI: ramipril) 2.5 to 10 mg/d
AmlodipineDrug
Also called DHPCCB
A dihydropyridine calcium channel blocker, (DHPCCB: amlodipine) 5 to 10 mg/d
MetoprololDrug
Also called BB
A sustained release beta-blocker, (BB: metoprolol) 50 to 200 mg/d

Study groups in NCT04364139
Study group	Role	What they receive
Lower BP goal and Ramipril	Experimental	Participants assigned to Lower Blood Pressure Goal (MAP less than or equal to 92 mm Hg) and Participants assigned to Receive Ramipril 2.5 to 10 mg/d Receives: Other: MAP goal less than or equal to 92 mm Hg; Drug: Ramipril
Usual BP goal and Ramipril	Experimental	Participants assigned to usual Blood Pressure Goal (MAP of 102 to 107 mm Hg) and participants assigned to Receive Ramipril 2.5 to 10 mg/d Receives: Other: MAP goal 102-107 mm Hg; Drug: Ramipril
Lower BP goal and Amlodipine	Experimental	Participants assigned to Lower Blood Pressure Goal (MAP less than or equal to 92 mm Hg) and Participants assigned to Receive Amlodipine 5 to 10 mg/d Receives: Other: MAP goal less than or equal to 92 mm Hg; Drug: Amlodipine
Usual BP goal and Amlodipine	Experimental	Participants assigned to usual Blood Pressure Goal (MAP of 102 to 107 mm Hg) and Participants assigned to Receive Amlodipine 5 to 10 mg/d Receives: Other: MAP goal 102-107 mm Hg; Drug: Amlodipine
Lower BP goal and Metoprolol	Experimental	Participants assigned to Lower Blood Pressure Goal (MAP less than or equal to 92 mm Hg) and Participants assigned to Receive Metoprolol 50 to 200 mg/d Receives: Other: MAP goal less than or equal to 92 mm Hg; Drug: Metoprolol
Usual BP goal and Metoprolol	Experimental	Participants assigned to usual Blood Pressure Goal (MAP of 102 to 107 mm Hg) and Participants assigned to Receive Metoprolol 50 to 200 mg/d Receives: Other: MAP goal 102-107 mm Hg; Drug: Metoprolol

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of change in GFR
GFR slope was determined separately during the first 3 months after randomization (acute phase) and during the remainder of follow-up (chronic phase)
Measured: Up to 3 years

Secondary outcomes (3)

Time to 50% reduction in GFR, ESRD, or death up to 3 years
Time from randomization to any of the following (1) confirmed reduction in GFR by 50% or by 25 mL/min per 1.73 m^2, (2) end stage renal disease (ESRD), or (3) death
Measured: Up to 3 years
Change in proteinuria
Change in proteinuria from baseline to the end of follow-up
Measured: Baseline to 3 years
Time to 50% reduction in GFR, ESRD, or death up to 10 years
Time from randomization to any of the following (1) confirmed reduction in GFR by 50% or by 25 mL/min per 1.73 m^2, (2) end stage renal disease (ESRD), or (3) death
Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 199530 Jun 2007

First posted27 Apr 2020
Study start1 Feb 1995
Primary completion30 Sep 2001
Study completion30 Jun 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Hypertensive NephrosclerosisStudies of the same condition, open and under way.
More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,094 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04364139
Sponsor's protocol ID: AASK U01DK048648
Other IDs: U01DK048648
Acronym: AASK
Status last verified: Apr 2020
First submitted: 23 Apr 2020
Last updated: 27 Apr 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Data and samples are available at the National Institute of Diabetes Digestive and Kidney Diseases (NIDDK) Central Repository

Publications

Agodoa LY, Appel L, Bakris GL, Beck G, Bourgoignie J, Briggs JP, Charleston J, Cheek D, Cleveland W, Douglas JG, Douglas M, Dowie D, Faulkner M, Gabriel A, Gassman J, Greene T, Hall Y, Hebert L, Hiremath L, Jamerson K, Johnson CJ, Kopple J, Kusek J, Lash J, Lea J, Lewis JB, Lipkowitz M, Massry S, Middleton J, Miller ER 3rd, Norris K, O'Connor D, Ojo A, Phillips RA, Pogue V, Rahman M, Randall OS, Rostand S, Schulman G, Smith W, Thornley-Brown D, Tisher CC, Toto RD, Wright JT Jr, Xu S; African American Study of Kidney Disease and Hypertension (AASK) Study Group. Effect of ramipril vs amlodipine on renal outcomes in hypertensive nephrosclerosis: a randomized controlled trial. JAMA. 2001 Jun 6;285(21):2719-28. doi: 10.1001/jama.285.21.2719.
PubMed 11386927
Appel LJ, Wright JT Jr, Greene T, Agodoa LY, Astor BC, Bakris GL, Cleveland WH, Charleston J, Contreras G, Faulkner ML, Gabbai FB, Gassman JJ, Hebert LA, Jamerson KA, Kopple JD, Kusek JW, Lash JP, Lea JP, Lewis JB, Lipkowitz MS, Massry SG, Miller ER, Norris K, Phillips RA, Pogue VA, Randall OS, Rostand SG, Smogorzewski MJ, Toto RD, Wang X; AASK Collaborative Research Group. Intensive blood-pressure control in hypertensive chronic kidney disease. N Engl J Med. 2010 Sep 2;363(10):918-29. doi: 10.1056/NEJMoa0910975.
PubMed 20818902
Wright JT Jr, Bakris G, Greene T, Agodoa LY, Appel LJ, Charleston J, Cheek D, Douglas-Baltimore JG, Gassman J, Glassock R, Hebert L, Jamerson K, Lewis J, Phillips RA, Toto RD, Middleton JP, Rostand SG; African American Study of Kidney Disease and Hypertension Study Group. Effect of blood pressure lowering and antihypertensive drug class on progression of hypertensive kidney disease: results from the AASK trial. JAMA. 2002 Nov 20;288(19):2421-31. doi: 10.1001/jama.288.19.2421.
PubMed 12435255
Heerspink HJL, Collier WH, Chaudhari J, Miao S, Tighiouart H, Appel GB, Caravaca-Fontan F, Floege J, Hannedouche T, Imai E, Jafar TH, Lewis JB, Li PKT, Locatelli F, Maes BD, Neuen BL, Perkovic V, Perrone RD, Remuzzi G, Schena FP, Wanner C, Greene T, Inker LA. A meta-analysis of albuminuria as a surrogate endpoint for kidney failure. Nat Med. 2026 Jan;32(1):281-287. doi: 10.1038/s41591-025-04057-z. Epub 2025 Nov 6.
PubMed 41198855

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: African American Study of Kidney Disease and Hypertension
ClinicalTrials.gov ID: NCT04364139
Acronym / sponsor ID: AASK / AASK U01DK048648
Conditions: Hypertensive Nephrosclerosis, Chronic Renal Insufficiency
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,094 participants (actual)
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
Collaborators: The Cleveland Clinic
Study start: 1 Feb 1995 (actual)
Primary completion: 30 Sep 2001 (actual)
Study completion: 30 Jun 2007 (actual)
First posted: 27 Apr 2020 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Lower BP goal and Ramipril	Experimental	Other: MAP goal less than or equal to 92 mm Hg, Drug: RamiprilParticipants assigned to Lower Blood Pressure Goal (MAP less than or equal to 92 mm Hg) and Participants assigned to Receive Ramipril 2.5 to 10 mg/d
Usual BP goal and Ramipril	Experimental	Other: MAP goal 102-107 mm Hg, Drug: RamiprilParticipants assigned to usual Blood Pressure Goal (MAP of 102 to 107 mm Hg) and participants assigned to Receive Ramipril 2.5 to 10 mg/d
Lower BP goal and Amlodipine	Experimental	Other: MAP goal less than or equal to 92 mm Hg, Drug: AmlodipineParticipants assigned to Lower Blood Pressure Goal (MAP less than or equal to 92 mm Hg) and Participants assigned to Receive Amlodipine 5 to 10 mg/d
Usual BP goal and Amlodipine	Experimental	Other: MAP goal 102-107 mm Hg, Drug: AmlodipineParticipants assigned to usual Blood Pressure Goal (MAP of 102 to 107 mm Hg) and Participants assigned to Receive Amlodipine 5 to 10 mg/d
Lower BP goal and Metoprolol	Experimental	Other: MAP goal less than or equal to 92 mm Hg, Drug: MetoprololParticipants assigned to Lower Blood Pressure Goal (MAP less than or equal to 92 mm Hg) and Participants assigned to Receive Metoprolol 50 to 200 mg/d
Usual BP goal and Metoprolol	Experimental	Other: MAP goal 102-107 mm Hg, Drug: MetoprololParticipants assigned to usual Blood Pressure Goal (MAP of 102 to 107 mm Hg) and Participants assigned to Receive Metoprolol 50 to 200 mg/d

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

African-American men and women (including black individuals born in the Caribbean, Africa, Canada, etc.) age 18 to 70 years. Each center will attempt to include equal numbers of men and women, at least 1:3 of each.
Hypertension is defined as a sitting diastolic BP of 95 mmHg or more. The average of the last two of three consecutive readings on a random zero sphygmomanometer machine at any visit is the level used. Hypertensive participants on anti-hypertensive therapy at Baseline need only one qualifying clinic visit. Those not currently on medications at Baseline must qualify on each of two consecutive clinic visits.
Reduced renal function, defined as a prerandomization (G1 visit) 125I-iothalamate GFR between 20 to 65 ml/min 1.73 per m^2.
Willingness and ability to cooperate with the protocol.

Key exclusion criteria (21 listed)

History of malignant or accelerated hypertension within 6 mo prior to study entry; previous chronic peritoneal or hemodialysis or renal transplantation.
Known secondary causes of hypertension.
Any known history of diabetes mellitus type I and II, or fasting (8-12 h) glucose >140 mg/dl on two occasions, or glucose >200 mg/dl on one occasion prior to randomization.
A ratio of urinary protein (mg/dl) to creatinine (mg/dl) exceeding 2.5 in a 24-h urine sample collected shortly before the initial GFR visit. (This ratio is used as an estimate of > 2.5 g/d proteinuria without needing to factor for validity of the collection.)
Clinical or renal biopsy evidence of any renal disease other than hypertensive nephrosclerosis. Persons with arteriographically documented renal arterial atherosclerotic disease less than 50% stenosis of the renal artery should be considered eligible for study participation if the principal investigator at the center feels the disease is not clinically significant.

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
MAP goal less than or equal to 92 mm HgLower Blood Pressure Goal (mean arterial pressure (MAP) less than or equal to 92 mm Hg) which corresponds to a BP of approximately 115/80 mmHg	Other	Lower BP goal and Amlodipine, Lower BP goal and Metoprolol, Lower BP goal and Ramipril
MAP goal 102-107 mm HgUsual Blood Pressure Goal (mean arterial pressure (MAP) 102-107 mm Hg) which corresponds to a BP of approximately 135/85 to 140/90 mmHg	Other	Usual BP goal and Amlodipine, Usual BP goal and Metoprolol, Usual BP goal and Ramipril
RamiprilAlso: ACEIAn angiotensin-converting enzyme inhibitor, (ACEI: ramipril) 2.5 to 10 mg/d	Drug	Lower BP goal and Ramipril, Usual BP goal and Ramipril
AmlodipineAlso: DHPCCBA dihydropyridine calcium channel blocker, (DHPCCB: amlodipine) 5 to 10 mg/d	Drug	Lower BP goal and Amlodipine, Usual BP goal and Amlodipine
MetoprololAlso: BBA sustained release beta-blocker, (BB: metoprolol) 50 to 200 mg/d	Drug	Lower BP goal and Metoprolol, Usual BP goal and Metoprolol

Primary outcome

Rate of change in GFR
Time frame: Up to 3 years
GFR slope was determined separately during the first 3 months after randomization (acute phase) and during the remainder of follow-up (chronic phase)

3 secondary outcomes

Time to 50% reduction in GFR, ESRD, or death up to 3 years
Time frame: Up to 3 years
Change in proteinuria
Time frame: Baseline to 3 years
Time to 50% reduction in GFR, ESRD, or death up to 10 years
Time frame: Up to 10 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
Results publication: PubMed 11386927Agodoa LY, Appel L, Bakris GL, Beck G, Bourgoignie J, Briggs JP, Charleston J, Cheek D, Cleveland W, Douglas JG, Douglas M, Dowie D, Faulkner M, Gabriel A, Gassman J, Greene T, Hall Y, Hebert L, Hiremath L, Jamerson K, Johnson CJ, Kopple J, Kusek J, Lash J, Lea J, Lewis JB, Lipkowitz M, Massry S, Middleton J, Miller ER 3rd, Norris K, O'Connor D, Ojo A, Phillips RA, Pogue V, Rahman M, Randall OS, Rostand S, Schulman G, Smith W, Thornley-Brown D, Tisher CC, Toto RD, Wright JT Jr, Xu S; African American Study of Kidney Disease and Hypertension (AASK) Study Group. Effect of ramipril vs amlodipine on renal outcomes in hypertensive nephrosclerosis: a randomized controlled trial. JAMA. 2001 Jun 6;285(21):2719-28. doi: 10.1001/jama.285.21.2719.
Results publication: PubMed 20818902Appel LJ, Wright JT Jr, Greene T, Agodoa LY, Astor BC, Bakris GL, Cleveland WH, Charleston J, Contreras G, Faulkner ML, Gabbai FB, Gassman JJ, Hebert LA, Jamerson KA, Kopple JD, Kusek JW, Lash JP, Lea JP, Lewis JB, Lipkowitz MS, Massry SG, Miller ER, Norris K, Phillips RA, Pogue VA, Randall OS, Rostand SG, Smogorzewski MJ, Toto RD, Wang X; AASK Collaborative Research Group. Intensive blood-pressure control in hypertensive chronic kidney disease. N Engl J Med. 2010 Sep 2;363(10):918-29. doi: 10.1056/NEJMoa0910975.
Results publication: PubMed 12435255Wright JT Jr, Bakris G, Greene T, Agodoa LY, Appel LJ, Charleston J, Cheek D, Douglas-Baltimore JG, Gassman J, Glassock R, Hebert L, Jamerson K, Lewis J, Phillips RA, Toto RD, Middleton JP, Rostand SG; African American Study of Kidney Disease and Hypertension Study Group. Effect of blood pressure lowering and antihypertensive drug class on progression of hypertensive kidney disease: results from the AASK trial. JAMA. 2002 Nov 20;288(19):2421-31. doi: 10.1001/jama.288.19.2421.
Derived from this study: PubMed 41198855Heerspink HJL, Collier WH, Chaudhari J, Miao S, Tighiouart H, Appel GB, Caravaca-Fontan F, Floege J, Hannedouche T, Imai E, Jafar TH, Lewis JB, Li PKT, Locatelli F, Maes BD, Neuen BL, Perkovic V, Perrone RD, Remuzzi G, Schena FP, Wanner C, Greene T, Inker LA. A meta-analysis of albuminuria as a surrogate endpoint for kidney failure. Nat Med. 2026 Jan;32(1):281-287. doi: 10.1038/s41591-025-04057-z. Epub 2025 Nov 6.
Individual participant dataSharing planned: Yes. Data and samples are available at the National Institute of Diabetes Digestive and Kidney Diseases (NIDDK) Central Repository

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.

JENNIFER GASSMAN principal investigator

CLEVELAND CLINIC LERNER COM-CWRU

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 21 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: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Rate of change in GFR (time frame: Up to 3 years). 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 NCT04364139, which also lists 4 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 27 Apr 2020.