Status unknownNCT03682952Updated Sep 26, 2018

Evaluation of Nail Fold Microcirculation in CKD

A Phase 4 interventional study of Alprostadil Injection and Beraprost sodium tablets in Chronic Renal Disease, sponsored by The Affiliated Hospital of Xuzhou Medical University. Status unknown at 1 site in China. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-26.

Sponsored by The Affiliated Hospital of Xuzhou Medical University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

Registered 7 months after the study started (first participant enrolled Feb 2018, registered Sep 2018).

Phase: Phase 4
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 20 Years to 70 Years
Sex: All

Study summary

To evaluation of nailfold microcirculation in patients with chronic renal failure and its intervention therapy

Read the detailed description

The aim of this study is to study the changes of Nailfold Microcirculation in patients with chronic renal failure, to clarify the correlation between the changes of Nailfold Microcirculation and renal function, and to explore whether nailfold microcirculation can be used as an indicator of renal microcirculation in patients with chronic renal failure, and to provide a noninvasive method for the clinical evaluation of renal microcirculation in patients with chronic renal failure.

Conditions studied

Chronic Renal Disease

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Keywords

Chronic Renal Disease
Nail fold microcirculation
Interventional therapy

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

The Affiliated Hospital of Xuzhou Medical University is the lead sponsor of 66 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

CKD patients
Without dialysis
Blood pressure ≤ 140/90mmHg

Exclusion criteria

Exclusion Criteria:

Polycystic kidney
Endocrine system disease
Cardio-cerebrovascular disease
Rheumatic immune disease
Peripheral vascular disease
Hematological diseases
Respiratory disease
Infection

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 100 participants (estimated)

Study arms

Experimental
Experimental group
Alprostadil and Beraprost sodium tablets are used to improve the microcirculation of CKD patients.
Drug: Alprostadil Injection · Drug: Beraprost sodium tablets
No intervention
Anemia control group
Anemia patients
No intervention
Control group
Healthy person

Interventions

DrugAlprostadil Injection
Participants are given alprostadil injection 10ug intravenously once a day for 2 weeks.
DrugBeraprost sodium tablets
Participants are given alprostadil injection 10ug intravenously once a day for 2 weeks ,then they take beraprost sodium tablets 40ug orally three times perday for 3 months.

What researchers measure

Primary outcomes

Nailfold microcirculation morphological integral
Nail fold capillary microscopy examination
Time frame: Up to three and a half months
Nailfold microcirculation blood flow integral
Nail fold capillary microscopy examination
Time frame: Up to three and a half months
Nail fold microcirculation perivascular loop integral
Nail fold capillary microscopy examination
Time frame: Up to three and a half months

Secondary outcomes

The content of blood serum creatinine
Intravenous blood sampling
Time frame: Up to three and a half months
The content of blood urea nitrogen
Intravenous blood sampling，uronoscopy
Time frame: Up to three and a half months
The content of blood cystatin C
Intravenous blood sampling
Time frame: Up to three and a half months
eGFR
Intravenous blood sampling
Time frame: Up to three and a half months
The content of blood albumin
Intravenous blood sampling
Time frame: Up to three and a half months
The quantification of urinary protein
Uronoscopy
Time frame: Up to three and a half months
The content of hemoglobin
Intravenous blood sampling
Time frame: Up to three and a half months

Study locations

1 site

The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu 221000, China

References and documents

Publications

Leunissen KM, van den Berg BW, Cheriex EC, Slaaf DW, Reneman RS, van Hooff JP. Influence of fluid removal during haemodialysis on macro- and skin microcirculation. Haemodynamic pathophysiologic study of fluid removal during haemodialysis. Nephron. 1990;54(2):162-8. doi: 10.1159/000185838. PubMed 2314527 ↗
Yuksel S, Pancar Yuksel E, Yenercag M, Soylu K, Zengin H, Gulel O, Meric M, Aydin F, Senturk N, Sahin M. Abnormal nail fold capillaroscopic findings in patients with coronary slow flow phenomenon. Int J Clin Exp Med. 2014 Apr 15;7(4):1052-8. eCollection 2014. PubMed 24955181 ↗
Senet P, Fichel F, Baudot N, Gaitz JP, Tribout L, Frances C. [Nail-fold capillaroscopy in dermatology]. Ann Dermatol Venereol. 2014 Jun-Jul;141(6-7):429-37. doi: 10.1016/j.annder.2014.04.120. Epub 2014 Jun 2. French. PubMed 24951141 ↗
Yuan SY. [Nail-fold microcirculatory flow in liver cirrhosis: diabetes mellitus and systemic lupus erythematosus]. Zhonghua Yi Xue Za Zhi. 1986 Aug;66(8):473-5, 512. No abstract available. Chinese. PubMed 3096534 ↗
Paparde A, Neringa-Martinsone K, Plakane L, Aivars JI. Nail fold capillary diameter changes in acute systemic hypoxia. Microvasc Res. 2014 May;93:30-3. doi: 10.1016/j.mvr.2014.02.013. Epub 2014 Mar 6. PubMed 24607833 ↗
Schumann L, Korten G, Holdt B, Holtz M. Microcirculation of the fingernail fold in CAPD patients: preliminary observations. Perit Dial Int. 1996 Jul-Aug;16(4):412-6. PubMed 8863336 ↗
Hasegawa K, Pereira BP, Pho RW. The microvasculature of the nail bed, nail matrix, and nail fold of a normal human fingertip. J Hand Surg Am. 2001 Mar;26(2):283-90. doi: 10.1053/jhsu.2001.21519. PubMed 11279575 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03682952
Lead sponsor: The Affiliated Hospital of Xuzhou Medical University
Responsible party: Sponsor
First posted: Sep 25, 2018
Start date: Feb 1, 2018
Primary completion: Apr 30, 2019 (estimated)
Completion: Apr 30, 2019 (estimated)
Last update: Sep 26, 2018

Study contacts

Dong Sun, MD

study director · The Affiliated Hospital of Xuzhou Medical University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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